Calcium Citrate Malate, Vita min D3 and Folic Acid Tablets SMPC, Taj Phar maceuticals

Calcium Citrate Malate, Vita min D3 and Folic Acid Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Calcium Citrate Malate, Vitamin D3 and Folic Acid Dosage & Rx Info | Calcium Citrate Malate, Vitamin D3 and Folic Acid Uses, Side Effects -: Indications, Side Effects, Warnings, Calcium Citrate Malate, Vita min D3 and Folic Acid - Drug Information - Taj Phar ma, Calcium Citrate Malat e, Vitamin D3 and Folic Acid dose Taj pharmaceuticals Calcium Citrate Malate, Vitamin D3 and Folic Acid interactions, Taj Pharmaceutical Calcium Citrate Malate, Vita min D3 and Folic Acid contraindications, Calcium Citrate Malate, Vitamin D3 and Folic Acid price, Calcium Citrate Malate, Vitamin D3 and Folic Acid Taj Phar ma Calciu m Citrate Malate, Vitamin D3 and Folic Acid Tablets SMPC- T aj Phar ma . Stay connected to all updated on Calcium Citrate Malate, Vitamin D3 and Folic Acid Taj Pharmaceuticals Taj phar maceuticals Hyderabad.

Adults
RX 2 tablets twice daily.

CALCIUM CITRATE Children

2 tablets per day in one or two divided doses.
MALATE, VITAMIN D3 The ability of the child to take CALCIUM
AND FOLIC ACID CITRATE tablets should be taken into account
before prescribing it to children, particularly to
TABLETS young children.
Renal impairment
1.NAME OF THE MEDICINAL PRODUCT CALCIUM CITRATE should not be used in
Calcium Citrate Malate, Vitamin D3 and Folic patients with severe renal impairment (see
Acid Tablets Contraindications & Special Warnings and
Special Precautions for Use). Using in patients
2. QUALITATIVE AND QUANTITATIVE with renal failure is contraindicated (see
COMPOSITION Contraindications).
Each film-coated tablet contains: Hepatic Impairment
Calcium Citrate Malate USP equivalent to No dose adjustment is required.
Calcium 250 mg
Cholecalciferol Concentrate (Powder Form) IP 4.3 Contraindications
equivalent to Cholecalciferol (Vitamin D3) 100 CALCIUM CITRATE is contraindicated in: •
IU hypersensitivity to the active substances or to
Folic Acid IP 50 mcg any of the excipients,
Excipients q.s. • hypercalcaemia, hypercalciuria,
Colour: Titanium Dioxide IP • nephrocalcinosis, nephrolithiasis,
• disease and/or conditions resulting in
3. PHARMACEUTICAL FORM hypercalcaemia and/or hypercalciuria (e.g.
primary hyperparathyroidism, myeloma, bone
Film coated tablets. metastases),
4. CLINICAL PARTICULARS • hypervitaminosis D,
• severe renal impairment and renal failure (see
4.1 Therapeutic indications Special Warnings and Special Precautions for
For the treatment of calcium and vitamin D Use).
deficiency state (pregnancy, lactation, growing
children). 4.4 Special Warnings and precautions for use

4.2 Posology and method of administration Long term treatment

During long-term treatment, serum calcium
The dose for children and adults may be levels should be followed and renal function
adjusted according to the dietary intake of should be monitored through measurements of
calcium, vitamin D and folic acid. serum creatinine. Monitoring is especially
important in patients on concomitant treatment
The duration of therapy depends on the response
with cardiac glycosides or thiazide diuretics (see
to therapy.
Interactions with Other Medicaments and Other
Additional calcium, vitamin D may be Forms of Interaction) and in patients with a high
supplemented through diet or other sources to tendency to calculus formation. In case of
fulfill the requirements. hypercalcaemia or signs of impaired renal
function the dose should be reduced or the
In case of Folic acid deficiency, additional treatment discontinued. Therapy should be
supplementation will be required through diet or reduced or preliminary interrupted, if urinary
other sources.
Calcium Citrate Malate, Vita min D3 and Folic Acid Tablets SMPC, Taj Phar maceuticals
Calcium Citrate Malate, Vita min D3 and Folic Acid Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Calcium Citrate Malate, Vitamin D3 and Folic Acid Dosage & Rx Info | Calcium Citrate Malate, Vitamin D3 and Folic Acid Uses, Side Effects -: Indications, Side Effects, Warnings, Calcium Citrate Malate, Vita min D3 and Folic Acid - Drug Information - Taj Phar ma, Calcium Citrate Malat e, Vitamin D3 and Folic Acid dose Taj pharmaceuticals Calcium Citrate Malate, Vitamin D3 and Folic Acid interactions, Taj Pharmaceutical Calcium Citrate Malate, Vita min D3 and Folic Acid contraindications, Calcium Citrate Malate, Vitamin D3 and Folic Acid price, Calcium Citrate Malate, Vitamin D3 and Folic Acid Taj Phar ma Calciu m Citrate Malate, Vitamin D3 and Folic Acid Tablets SMPC- T aj Phar ma . Stay connected to all updated on Calcium Citrate Malate, Vitamin D3 and Folic Acid Taj Pharmaceuticals Taj phar maceuticals Hyderabad.

calcium level exceeds 7.5 mmol/24 h (300 4.5 Interaction with other medicinal products
mg/24 h). and other forms of interaction
Sarcoidosis Phenytoin, barbiturates
CALCIUM CITRATE should be prescribed
with caution to patients suffering from Concomitant use of phenytoin or barbiturates
sarcoidosis, due to the risk of increased may reduce the effect of vitamin D3 since the
metabolism increases.
metabolism of vitamin D into its active form.
These patients should be monitored with regard Antiepileptics
to the calcium content in serum and urine.
Folic acid has been reported to decrease serum
Immobilised patients with Osteoporosis concentrations of phenobarbital and phenytoin.
CALCIUM CITRATE should be used Antiepileptics may produce folate deficiency
cautiously in immobilised patients with states. Replacement therapy with folinic acid or
osteoporosis due to increased risk of folic acid may become necessary during
hypercalcaemia. antiepileptic therapy in order to prevent
development of megaloblastic anaemia
Renal impairment
Vitamin D should be used with caution in Thiazide diuretics
patients with impairment of renal function and
the effect on calcium and phosphate levels Thiazide diuretics reduce the urinary excretion
should be monitored. Patients with renal of calcium. Due to increased risk of
impairment are at potential risk of hypercalcaemia, serum calcium should be
hyperphosphaetemia, nephrolithiasis and regularly monitored during concomitant use of
nephrocalcinosis. The risk of soft tissue thiazide diuretics.
calcification should be taken into account. In Corticosteroids
patients with severe renal insufficiency, vitamin
D in the form of cholecalciferol is not Systemic corticosteroids reduce calcium
metabolised normally and other forms of absorption. During concomitant use, it may be
vitamin D should be used (see necessary to increase the dose of CALCIUM
Contraindications). CITRATE .

Other medicinal products containing calcium Ion exchange resins, liquid paraffin
or vitamin D Simultaneous treatment with ion exchange resins
The content of vitamin D in CALCIUM such as cholestyramine or laxatives such as
CITRATE should be considered when paraffin oil may reduce the gastrointestinal
prescribing other medicinal products containing absorption of vitamin D. Therefore a time
vitamin D. Additional doses of calcium or interval as long as possible between the intakes
vitamin D should be taken under close medical 3 should be recommended.
supervision. In such cases it is necessary to
monitor serum calcium levels and urinary Tetracyclines
calcium excretion frequently. Calcium and
Calcium may interfere with the absorption of
vitamin D intake from other sources (food,
concomitantly administered tetracycline
dietary supplements) should be estimated, before
preparations. For this reason, tetracycline
prescribing the product.
preparations should be administered at least two
Tetracyclines or quinolones hours before or four to six hours after oral intake
Co-administration with tetracyclines or of calcium.
quinolones is usually not recommended, or must
Quinolone
be done with precaution (see Interaction with
Other Medicaments and Other Forms of The absorption of quinolone antibiotics may be
Interaction). impaired if administered concomitantly with
calcium. Quinolone antibiotics should be taken
Calcium Citrate Malate, Vita min D3 and Folic Acid Tablets SMPC, Taj Phar maceuticals
Calcium Citrate Malate, Vita min D3 and Folic Acid Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Calcium Citrate Malate, Vitamin D3 and Folic Acid Dosage & Rx Info | Calcium Citrate Malate, Vitamin D3 and Folic Acid Uses, Side Effects -: Indications, Side Effects, Warnings, Calcium Citrate Malate, Vita min D3 and Folic Acid - Drug Information - Taj Phar ma, Calcium Citrate Malat e, Vitamin D3 and Folic Acid dose Taj pharmaceuticals Calcium Citrate Malate, Vitamin D3 and Folic Acid interactions, Taj Pharmaceutical Calcium Citrate Malate, Vita min D3 and Folic Acid contraindications, Calcium Citrate Malate, Vitamin D3 and Folic Acid price, Calcium Citrate Malate, Vitamin D3 and Folic Acid Taj Phar ma Calciu m Citrate Malate, Vitamin D3 and Folic Acid Tablets SMPC- T aj Phar ma . Stay connected to all updated on Calcium Citrate Malate, Vitamin D3 and Folic Acid Taj Pharmaceuticals Taj phar maceuticals Hyderabad.

two hours before or six hours after intake of Folic acid antagonists
calcium.
Folate deficiency states may be produced by
Penicillamine & Isoniazid folic acid antagonists such as methotrexate,
pyrimethamine, triamterene, trimethoprim and
Penicillamine (a chelating agent) and sulfonamides.
antituberculous drugs (such as isoniazid) may
increase the requirements for folic acid. 4 Oral contraceptives
Cardiac glycosides Serum concentration of folic acid may be
decreased by use of oral contraceptives. Alcohol
Hypercalcaemia may increase the toxicity of
cardiac glycosides during treatment with Alcohol
calcium and vitamin D. Patients should be
monitored with regard to electrocardiogram may produce folate deficiency states.
(ECG) and serum calcium levels. Orlistat
Bisphosphonate Treatment with orlistat may potentially impair
the absorption of fat-soluble vitamins, e.g.
If a bisphosphonate is used concomitantly, this
vitamin D3.
preparation should be administered at least one
hour before the intake of CALCIUM CITRATE 4.6 Fertility, Pregnancy and lactation
since gastrointestinal absorption of may be
reduced. Fertility

Sodium fluoride Normal endogenous levels of calcium and

vitamin D are not expected to have any adverse
Calcium may also reduce absorption of sodium effects on fertility.
fluoride and such preparations should be
administered at least three hours before the Pregnancy
intake of CALCIUM CITRATE . Calcium /cholecalciferol can be used during
Iron, zinc and strontium ranelate pregnancy, in case of a calcium and vitamin D
deficiency. The daily intake should not exceed
Calcium salts may decrease the absorption of 1,500 mg of calcium and 600 I.U. of vitamin D.
iron, zinc and strontium ranelate. Consequently,
iron, zinc or strontium ranelate preparations Studies in animals have shown reproductive
should be taken at least two hours before or after toxicity of high doses of vitamin D.
calcium/cholecalciferol. In pregnant women, overdoses of calcium and
Oxalic acid, phytic acid vitamin D should be avoided, as permanent
hypercalcaemia has been related to adverse
Oxalic acid (found in spinach and rhubarb) and effects on developing foetus.
phytic acid (found in whole cereals) may inhibit
calcium absorption through formation of The physiological requirement of folic acid
insoluble compounds with calcium ions. The during pregnancy cannot be met with
patient should not take calcium products within CALCIUM CITRATE alone. Additional folic
two hours of eating foods high in oxalic acid and acid should be supplemented through diet or
phytic acid. other sources to fulfill the folic acid
requirements during pregnancy and lactation
Levothyroxine
Lactation
The efficacy of levothyroxine can be reduced by
the concurrent use of calcium, due to decreased Calcium /cholecalciferol can be used during
levothyroxine absorption. Administration of breast-feeding.
calcium and levothyroxine should be separated Calcium passes slightly into breast-milk, without
by at least four hours. having a negative effect on children.
Calcium Citrate Malate, Vita min D3 and Folic Acid Tablets SMPC, Taj Phar maceuticals
Calcium Citrate Malate, Vita min D3 and Folic Acid Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Calcium Citrate Malate, Vitamin D3 and Folic Acid Dosage & Rx Info | Calcium Citrate Malate, Vitamin D3 and Folic Acid Uses, Side Effects -: Indications, Side Effects, Warnings, Calcium Citrate Malate, Vita min D3 and Folic Acid - Drug Information - Taj Phar ma, Calcium Citrate Malat e, Vitamin D3 and Folic Acid dose Taj pharmaceuticals Calcium Citrate Malate, Vitamin D3 and Folic Acid interactions, Taj Pharmaceutical Calcium Citrate Malate, Vita min D3 and Folic Acid contraindications, Calcium Citrate Malate, Vitamin D3 and Folic Acid price, Calcium Citrate Malate, Vitamin D3 and Folic Acid Taj Phar ma Calciu m Citrate Malate, Vitamin D3 and Folic Acid Tablets SMPC- T aj Phar ma . Stay connected to all updated on Calcium Citrate Malate, Vitamin D3 and Folic Acid Taj Pharmaceuticals Taj phar maceuticals Hyderabad.

Vitamin D and its metabolites also pass into may include anorexia, nausea, vomiting, thirst,
breast-milk. This should be considered when polydipsia, polyuria, constipation, abdominal
giving additional vitamin D to the child. pain, muscle weakness, fatigue, mental
disturbances, bone pain, nephrocalcinosis, renal
Folic acid is excreted in breast milk.
calculi and in severe cases cardiac arrythmias.
4.7 Effects on ability to drive and use Extreme hypercalcemia may result in coma and
machines death. Persistently high calcium levels may lead
There are no clinical data proving that the to irreversible renal damage and soft tissue
contents of CALCIUM CITRATE may have an calcification.
influence on the ability to drive or use machines.
The threshold for vitamin D intoxication is
4.8 Undesirable Effects between 40,000 and 100,000 I.U./day for 1-2
Clinical Trial Data months in persons with normal parathyroid
There are no relevant data available function, for calcium in excess of 2.000 mg per
day.
Post Marketing Data
Adverse drug reactions (ADRs) are listed below There are no reports of folic acid overdosage in
by MedDRA system organ class and by the literature.
frequency.
Treatment
Frequencies are defined as: In the case of intoxication, treatment should be
Very common ≥1/10 stopped immediately and the fluid deficiency
Common ≥1/100 to < 1/10 should be balanced. Treatment with thiazide
Uncommon ≥1/1000 to < 1/100 diuretics, lithium, vitamin A, vitamin D and
Rare ≥1/10000 to < 1/1000 cardiac glycosides must also be discontinued.
Very rare< 1/1000 Rehydration and, according to severity, isolated
Not known (cannot be estimated from the
or combined treatment with loop diuretics,
available data).
bisphosphonates, calcitonin and corticosteroids
Immune system disorders should be given. Serum electrolytes, renal
Not known: hypersensitivity reactions (see Skin function and diuresis must be monitored. In
and subcutaneous tissue disorders; Respiratory, severe cases ECG and CVP should be followed.
thoracic and mediastinal disorders), anaphylactic Further management should be as clinically
reaction.
indicated
Metabolism and nutrition disorders
5. PHARMACOLOGICAL PROPERTIES
Uncommon: hypercalcaemia, hypercalciuria.
5.1 Pharmacodynamic properties
Respiratory, thoracic and mediastinal disorders
Not known: laryngeal oedema.
Nearly all (99%) of total body calcium is located
Gastrointestinal disorders in the skeleton. The remaining 1% is equally
Rare: nausea, diarrhea, abdominal pain, distributed between the teeth and soft tissues,
constipation, flatulence, abdominal distension. with only 0.1% in the extracellular fluid (ECF).
Not known: vomiting. In the skeleton it constitutes 25% of the dry
weight. Calcium in form of calcium phosphate
Skin and subcutaneous tissue disorders Rare: which approximates hydroxyapatite
rash, pruritus, urticaria. [Ca10(OH)2(PO4)6] and embedded in collagen
Not known: angioedema. fibrils provide rigidity to the skeleton. Calcium
4.9 Overdose ions play a role in many, if not most, metabolic
processes. Calcium is essential, both during
Symptoms and signs pregnancy and lactation, for proper formation of
Overdosage can lead to hypervitaminosis and bones and teeth of the offspring, for secretion of
hypercalcaemia. Symptoms of hypercalcaemia breastmilk rich in calcium and to prevent
Calcium Citrate Malate, Vita min D3 and Folic Acid Tablets SMPC, Taj Phar maceuticals
Calcium Citrate Malate, Vita min D3 and Folic Acid Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Calcium Citrate Malate, Vitamin D3 and Folic Acid Dosage & Rx Info | Calcium Citrate Malate, Vitamin D3 and Folic Acid Uses, Side Effects -: Indications, Side Effects, Warnings, Calcium Citrate Malate, Vita min D3 and Folic Acid - Drug Information - Taj Phar ma, Calcium Citrate Malat e, Vitamin D3 and Folic Acid dose Taj pharmaceuticals Calcium Citrate Malate, Vitamin D3 and Folic Acid interactions, Taj Pharmaceutical Calcium Citrate Malate, Vita min D3 and Folic Acid contraindications, Calcium Citrate Malate, Vitamin D3 and Folic Acid price, Calcium Citrate Malate, Vitamin D3 and Folic Acid Taj Phar ma Calciu m Citrate Malate, Vitamin D3 and Folic Acid Tablets SMPC- T aj Phar ma . Stay connected to all updated on Calcium Citrate Malate, Vitamin D3 and Folic Acid Taj Pharmaceuticals Taj phar maceuticals Hyderabad.

osteoporosis in the mother. Vitamin D is calcium in the plasma is bound to proteins,

required to maintain normal blood levels of primarily albumin; about 50% of calcium in the
calcium and phosphate, which are in turn needed plasma is diffusible ionic calcium and about
for the normal mineralization of bone, muscle 10% is diffusible, but it is complexed with
contraction, nerve conduction, and general anions such as phosphate and citrate.
cellular function in all cells of the body. Vitamin
D achieves this after its conversion to the active Cholecalciferol
About 50-80% of the ingested vitamin D is
form 1,25- dihydroxyvitamin D [1,25-(OH)2D],
absorbed in the small intestine. It is carried to
or calcitriol. This active form regulates 7 the
transcription of a number of vitamin D- the blood stream by lymphatics and it binds to
dependent genes which code for calcium- alpha-globulin vitamin D in the blood. A large
transporting proteins and bone matrix proteins. fraction of the circulating vitamin D is extracted
Vitamin D also modulates the transcription of by the hepatocytes and converted to 25-hydroxy
cell cycle proteins, which decrease cell vitamin D (25(OH)D) with the help of the
proliferation and increase cell differentiation of enzyme, 25-hydroxylase. 25(OH)D is the major
a number of specialized cells of the body (e.g. circulating form of vitamin D and it is actively
converted to 1,25-dihydroxyvitamin D in the
osteoclastic precursors, enterocytes,
keratinocytes). This property may explain the kidneys by the enzyme 125-hydroxyvitamin D1-
actions of vitamin D in bone resorption, alphahydroxylase. Deactivation of 1,25-
intestinal calcium transport, and skin. dihydroxyvitamin D and 25(OH)D occurs by
CYP24. Vitamin D and its metabolites are
Administration of calcium and vitamin D3 primarily excreted via the biliary root. The final
counteracts the increase of parathyroid hormone degradation product of 1,25- dihydroxyvitamin
(PTH) which is caused by calcium deficiency D is calcitroic acid, which is excreted by the
and which cause increased bone resorption kidneys. Folic acid Folic acid is absorbed in the
small intestine and transported to the liver. In the
Folic acid is essential for erythropoiesis,
liver it is metabolized to polyglutamate forms
maturation of red blood cells and biosynthesis of
and released into the circulation and to the bile.
the DNA.
The principal folate in the plasma is 5-
5.2 Pharmacokinetic properties methyltetrahydrofolate in its monoglutate form.
About two-thirds of folate in plasma is protein
Calcium citrate malate bound. All tissue forms of folate are
Calcium is absorbed from small intestine in polyglutamates, while circulating forms are
ionic form by both active and passive monoglutamates. Folate is excreted in the urine
mechanisms. Overall, results from human and as folate cleavage products. Intact folate is
animal studies show that calcium from calcium reabsorbed into proximal convoluted tubule.
citrate malate is more bioavailable (8–15%) than Folate is excreted in bile and much of it is
calcium from some other calcium sources. reabsorbed via the enterohepatic circulation.
Citrate and malate anions chelated to calcium in
calcium citrate malate are considered to enhance Clinical Studies
calcium absorption, possibly by forming A clinical study of institutionalised patients
relatively stable soluble complexes, such that suffering from vitamin D deficiency indicated
precipitation of calcium by phosphate in the gut that a daily intake of 1000 mg calcium and 800
is not chemically favored and the likelihood of IU vitamin D for six months normalised the
calcium absorption is improved. Active value of the 25-hydroxylated metabolite of
mechanism for calcium absorption depends on vitamin D3 and reduced secondary
the action of the active form of vitamin D, 1,25- hyperparathyroidism and alkaline phosphatases.
dihydroxycholecalciferol. Calcium that is An 18 month double-blind, placebo controlled
unabsorbed from intestine is excreted in feces. study including 3270 institutionalised women
Greater than 98% of calcium from glomerular aged 84 (± 6 years) who received
filtrate is reabsorbed. Approximately 40% of supplementation of vitamin D (800 IU/day) and
calcium phosphate (corresponding to 8 1200
Calcium Citrate Malate, Vita min D3 and Folic Acid Tablets SMPC, Taj Phar maceuticals
Calcium Citrate Malate, Vita min D3 and Folic Acid Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Calcium Citrate Malate, Vitamin D3 and Folic Acid Dosage & Rx Info | Calcium Citrate Malate, Vitamin D3 and Folic Acid Uses, Side Effects -: Indications, Side Effects, Warnings, Calcium Citrate Malate, Vita min D3 and Folic Acid - Drug Information - Taj Phar ma, Calcium Citrate Malat e, Vitamin D3 and Folic Acid dose Taj pharmaceuticals Calcium Citrate Malate, Vitamin D3 and Folic Acid interactions, Taj Pharmaceutical Calcium Citrate Malate, Vita min D3 and Folic Acid contraindications, Calcium Citrate Malate, Vitamin D3 and Folic Acid price, Calcium Citrate Malate, Vitamin D3 and Folic Acid Taj Phar ma Calciu m Citrate Malate, Vitamin D3 and Folic Acid Tablets SMPC- T aj Phar ma . Stay connected to all updated on Calcium Citrate Malate, Vitamin D3 and Folic Acid Taj Pharmaceuticals Taj phar maceuticals Hyderabad.

mg/day of elemental calcium), showed a

significant decrease of PTH secretion.
After 18 months, an "intent-to treat" analysis
showed 80 hip fractures in the calcium-vitamin Manufactured in India by:
D group and 110 hip fractures in the placebo TAJ PHARMACEUTICALS LTD.
group (p=0.004). A follow-up study after 36 Mumbai, India
months showed 137 women with at least one hip At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad
fracture in the calcium-vitamin D group 438225, Gujarat, INDIA
(n=1176) and 178 in the placebo group (n=1127)
This leaflet was last revised in October 2019
(p <0.02).
5.3 Preclinical safety data
At Vitamin D doses far higher than the human
therapeutic range teratogenicity has been
observed in animal studies.
6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maize Starch, Methylparaben, Propylparaben,
Polyvinylpyrrolidone K-30, Colloidal Silicon
Dioxide (Degussa) and Magnesium Stearate.
Film-Coating:
Instacoat Universal (Code No. IC-U-3521)*
*Instacoat Universal (Code No. IC-U-3521)
contains: Hydroxy propyl methyl cellulose,
Polyethylene glycol, Talc, Titanium dioxide.
6.2 Incompatibilities
There are no relevant data available.
6.3 Shelf life
The expiry date is indicated on the label and
packaging.
6.4 Special precautions for storage
Store the container well closed at a temperature
not exceeding 30°C. Protect from light and
moisture. Keep out of reach of children.
6.5 Nature and contents of container
Bottles containing tablets in a carton.
6.6 Special precautions for disposal and other
handling
There are no special requirements for use or
handling of this product.
7. MANUFACTURER: