ROBITUSSIN MAXIMUM STRENGTH 12 HOUR COUGH AND MUCUS RELIEF- dextromethorphan hydrobromide, guaifenesin tablet, extended release

Robitussin Maximum Strength 12 Hour Cough and Mucus Relief by

Drug Labeling and Warnings

Robitussin Maximum Strength 12 Hour Cough and Mucus Relief by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each extended-release tablet)	Purposes
Dextromethorphan HBr 60 mg	Cough suppressant
Guaifenesin 1200 mg	Expectorant

INDICATIONS & USAGE

Uses

• 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

Warnings

Do not use

• 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.

Ask a doctor before use 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 using this product

• do not use more than directed

Stop use and ask 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 breast-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 (1-800-222-1222).

DOSAGE & ADMINISTRATION

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 tablet every 12 hours; not more than 2 tablets in 24 hours
• children under 12 years of age: do not use

STORAGE AND HANDLING

Other information

• each tablet contains: magnesium 25 mg
• store between 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide

QUESTIONS

Questions?

call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

SPL UNCLASSIFIED SECTION

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Tablet Blister Pack

PUSH TABLET THROUGH FOIL

Robitussin® Maximum Strength
12 Hour Cough & Mucus Relief
Extended-Release Tablet

Guaifenesin 1200 mg
Dextromethorphan HBr 60 mg
Extended-Release Tablet

Dist. by: Pfizer, Madison, NJ 07940 USA
©2019 Pfizer Inc.

LOT
EXP

PRINCIPAL DISPLAY PANEL - 8 Tablet Blister Pack Carton

NEW!

Robitussin®

MAXIMUM STRENGTH
12 Hour
Cough & Mucus Relief
EXTENDED-RELEASE TABLETS

GUAIFENESIN & DEXTROMETHORPHAN HYDROBROMIDE
1200 mg/60 mg EXTENDED-RELEASE TABLETS

Expectorant & Cough Suppressant

Actual Size

✓Controls Cough

✓Thins & Loosens Mucus

8
EXTENDED-RELEASE TABLETS

INGREDIENTS AND APPEARANCE

ROBITUSSIN MAXIMUM STRENGTH 12 HOUR COUGH AND MUCUS RELIEF 
dextromethorphan hydrobromide, guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-8765
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	60 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	1200 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	YELLOW	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	2424
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8765-04	1 in 1 CARTON	06/14/2019
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0031-8765-08	1 in 1 CARTON	06/14/2019
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0031-8765-16	2 in 1 CARTON	06/14/2019
3		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207602	06/14/2019

Labeler - Wyeth Consumer Healthcare LLC (828831730)