MUCINEX DM- guaifenes in and dextromethorphan hydrobromide tablet, extended releas e

RB Health (US) LLC

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Mucinex®DM
Drug Facts

Active ingredients (in each extended-release bi-

Purposes
layer tablet)
Dextromethorphan HBr 30 mg Cough suppressant
Guaifenesin 600 mg Expectorant

Us es
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of
bothersome mucus and make coughs more productive
temporarily relieves:
cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled
irritants
the intensity of coughing
the impulse to cough to help you get to sleep

Warnings

Do not us e
for children under 12 years of age
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 your prescription drug contains an MAOI, ask a
doctor or pharmacist before taking this product.

As k a doctor before us e if you have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)

When us ing this product

do not use more than directed

Stop us e and as k a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These
could be signs of a serious illness.

If pregnant or breas t-feeding, ask a health professional 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 crush, chew, or break tablet
take with a full glass of water
this product can be administered without regard for timing of meals
 adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24
hours
children under 12 years of age: do not use

Other information
store at 20-25°C (68-77°F)

Inactive ingredients
carbomer homopolymer type B; D&C yellow #10 aluminum lake; hypromellose, USP; magnesium
stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Ques tions ?
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
Made in England

PRINCIPAL DISPLAY PANEL - 20 Tablet Blis ter Pack Carton

NDC 63824-056-32
Mucinex®DM
600 mg guaifenesin & 30 mg dextromethorphan HBr
extended-release bi-layer tablets
EXPECTORANT & COUGH SUPPRESSANT
12
HOUR®

Controls Cough
Thins and Loosens Mucus
Immediate and Extended Release

20
EXTENDED-RELEASE
BI-LAYER TABLETS
MUCINEX DM
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Prod uct T yp e HUMAN O TC DRUG Ite m Cod e (S ource ) NDC:6 38 24-0 56

Route of Ad minis tration O RAL

Active Ing redient/Active Moiety

Ing redient Name Basis o f Streng th Streng th
Gua ife ne sin (UNII: 49 5W7451VQ ) (Gua ife ne sin - UNII:49 5W7451VQ ) Gua ife ne sin 6 0 0 mg
De xtro me tho rpha n Hydro bro mide (UNII: 9 D2RTI9 KYH) (De xtro me tho rpha n - De xtro me tho rpha n
30 mg
UNII:7355X3RO TS) Hydro bro mide

Inactive Ing redients

Ing redient Name Streng th
Ca rbo me r Ho mo po lyme r Type B ( Allyl Pe nta e rythrito l Cro sslinke d) (UNII: HHT0 1ZNK31)
D&C ye llo w no . 10 (UNII: 35SW5USQ 3G)
a luminum o xide (UNII: LMI26 O 6 9 33)
HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO )
ma g ne sium ste a ra te (UNII: 70 0 9 7M6 I30 )
MICRO CRYSTALLINE CELLULO SE (UNII: O P1R32D6 1U)

Product Characteristics
Color WHITE (ye llo w a nd white ) S core no sc o re
S hap e O VAL S iz e 16 mm
Flavor Imp rint Cod e Muc ine x;6 0 0
Contains

Packag ing
# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date
NDC:6 38 24-0 56 -
1 4 in 1 CARTO N 0 3/30 /20 18
89
1 17 in 1 BLISTER PACK; Type 0 : No t a Co mbina tio n Pro duc t
2 NDC:6 38 24-0 56 -36 1 in 1 CARTO N 0 6 /26 /20 12
2 6 in 1 BLISTER PACK; Type 0 : No t a Co mbina tio n Pro duc t
3 NDC:6 38 24-0 56 -32 1 in 1 CARTO N 0 6 /26 /20 12
20 in 1 BLISTER PACK; Type 0 : No t a Co mbina tio n
3
Pro duc t
4 NDC:6 38 24-0 56 -34 2 in 1 CARTO N 0 6 /26 /20 12
20 in 1 BLISTER PACK; Type 0 : No t a Co mbina tio n
4
Pro duc t
NDC:6 38 24-0 56 -
5 3 in 1 CARTO N 0 6 /26 /20 12
69
20 in 1 BLISTER PACK; Type 0 : No t a Co mbina tio n
5
Pro duc t
6 NDC:6 38 24-0 56 -74 24 in 1 CARTO N 0 6 /26 /20 12
6 NDC:6 38 24-0 56 -73 2 in 1 PO UCH; Type 0 : No t a Co mbina tio n Pro duc t
7 NDC:6 38 24-0 56 -72 2 in 1 PO UCH; Type 0 : No t a Co mbina tio n Pro duc t 0 6 /26 /20 12
 8 NDC:6 38 24-0 56 -11 2 in 1 CARTO N 0 6 /26 /20 12
8 12 in 1 BLISTER PACK; Type 0 : No t a Co mbina tio n Pro duc t
9 NDC:6 38 24-0 56 -0 1 5 in 1 CARTO N 0 6 /26 /20 12
20 in 1 BLISTER PACK; Type 0 : No t a Co mbina tio n
9
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
NDA NDA0 216 20 0 6 /26 /20 12

Labeler - RB Health (US) LLC (081049410)

Revised: 10/2019 RB Health (US) LLC