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ALTILAN CL- dextromethorphan hbr, phenylephrine hcl, chlorpheniramine maleate liquid

Alternative Pharmacal Corporation


Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they
comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Active Ingredients (in each 5 mL) Purpos e


Dextromethorphan HBr.............. 15 mg ........ Cough suppressant
Phenylephrine HCL .................. 10 mg ...... Nasal Decongestant
Chlorpheniramine Maleate........ 4 mg ........ Antihistamine

Cough suppressant
Nasal Decongestant
Antihistamine

Us es
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily
relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Warnings
DO NOT USE
If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,
psychiatric or emotional conditions or Parkinson's disease), or for 2 weeks after stopping the MAOI
drug. If you do not know if you are taking a prescription drug that contains MAOI; ask your doctor or
pharmacist before taking this product.
As k a doctor before us e if you have:
A persistant cough may be a sign of a serious condition. If cough persists for more than a week, tends to
recur, or is accompanied by fever, rash, or persistent headache.
When us ing this product
do not exceed the recommended dosage
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery

When us ing this prouct do not us e more than directed.


Stop us e and as k a doctor before us e if: cough lasts more than 7 days, comes back, or is
accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breas t-feeding, ask a health profession before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control
Center right away.

Directions Do not take more than 6 doses in any 24-hour period.

Age Dose
Adults and children 12 years of age and over 5 ml (1 tsp) every 4 hours
Children 6 years to under 12 years of age 2.5 ml (1/2 tsp) every 4 hours
Children under 6 years of age ask a doctor

Other Information
Store at room temperature 15 0 - 30 0 C (59 0 -86 0 F)
Tamper Evident Feature: Do not use if seal under cap is torn, broken or missing. Avoid excessive
heat or humidity.

Inactiveingredients
Cherry flavor, citric acid, glycerin, hydroxyethylcellulose, methylparaben, potssium sorbate, propylene
glycol, propylparaben, purified water, sodium citrate, and sucralose

Ques tions or comments ? 1-786-507-1566

ALTILAN CL
dextromethorphan hbr, phenylephrine hcl, chlorpheniramine maleate liquid

Product Information
Prod uct T yp e HUMAN O TC DRUG Ite m Cod e (S ource ) NDC:5316 3-114

Route of Ad minis tration O RAL

Active Ing redient/Active Moiety


Ing redient Name Basis o f Streng th Streng th
DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH) DEXTRO METHO RPHAN 15 mg
(DEXTRO METHO RPHAN - UNII:7355X3RO TS) HYDRO BRO MIDE in 5 mL
PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE - PHENYLEPHRINE 10 mg
UNII:1WS29 7W6 MV) HYDRO CHLO RIDE in 5 mL
CHLO RPHENIRAMINE MALEATE (UNII: V1Q 0 O 9 O J9 Z) (CHLO RPHENIRAMINE - CHLO RPHENIRAMINE 4 mg
UNII:3U6 IO 19 6 5U) MALEATE in 5 mL

Inactive Ing redients


Ing redient Name Streng th
ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6 A3C0 O X)
HYDRO XYETHYL CELLULO SE ( 10 0 MPA.S AT 2 %) (UNII: R33S7TK2EP)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q 16 7V3)
PRO PYLPARABEN (UNII: Z8 IX2SC1O H)
WATER (UNII: 0 59 Q F0 KO 0 R)
SO DIUM CITRATE (UNII: 1Q 73Q 2JULR)
SUCRALO SE (UNII: 9 6 K6 UQ 3ZD4)

Packag ing
# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date
1 NDC:5316 3-114-16 473 mL in 1 BO TTLE; Type 0 : No t a Co mbina tio n Pro duc t

Marketing Information
Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
O TC mo no gra ph fina l pa rt341 0 3/0 1/20 15

Labeler - Alternative Pharmacal Corporation (078528214)

Revised: 6/2015 Alternative Pharmacal Corporation