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

----------

Drug Facts

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Purposes

Cough suppressant

Expectorant

Uses

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).

Directions

Other information

Inactive ingredients

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

Questions?

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

Distributed by: Pfizer, Madison, NJ 07940 USA

Principal Display Panel

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

8EXTENDED-RELEASE TABLETS

Robitussin 12 Hr Cough 1200mg/60mg ER Tabs
ROBITUSSIN MAXIMUM STRENGTH 12 HOUR COUGH AND MUCUS RELIEF 
dextromethorphan hydrobromide, guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8765
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColoryellowScoreno score
ShapeOVALSize22mm
FlavorImprint Code 2424
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8765-041 in 1 CARTON06/14/2019
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0031-8765-081 in 1 CARTON06/14/2019
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0031-8765-162 in 1 CARTON06/14/2019
38 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20760206/14/2019
Labeler - Haleon US Holdings LLC (079944263)

Revised: 4/2024
Document Id: 158a1612-05f6-cc2e-e063-6294a90ab9ef
Set id: 96409b52-b0ec-444b-bc39-fd41070e9855
Version: 5
Effective Time: 20240407
 
Haleon US Holdings LLC