ROBITUSSIN HONEY MAXIMUM STRENGTH COUGH AND CHEST CONGESTION DM- dextromethorphan hbr, guaifenesin solution 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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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Drug Facts

Drug Facts

Active ingredients (in each 20 ml)Purposes

Dextromethorphan HBr, USP 20 mg

Cough suppressant

Guaifenesin, USP 400 mg

Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor 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 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.

Directions

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided
keep dosing cup with product
ml = milliliter
this adult product is not intended for use in children under 12 years of age
agedose

adults and children 12 years and over

20 ml every 4 hours

children under 12 years

do not use

Other information

each 20 ml contains: sodium 21 mg
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Questions or comments?

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

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

ADULT

Robitussin®

Honey

MAXIMUM STRENGTH

Cough+Chest
Congestion DM

DM
MAX

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

NON-DROWSY

4 FL OZ (118 ml)

Principal Display Panel - 118 ml Bottle Label

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

ADULT

NEW!

Robitussin®

Honey

Cough+Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

NON-DROWSY

MAXIMUM STRENGTH

1.
Controls Cough
2.
Relieves Chest Congestion
3.
Thins & Loosens Mucus

Taste the
Real Honey

DM
MAX

For Ages 12+
4 FL OZ (118 ml)

Principal Display Panel - 118 ml Bottle Carton
ROBITUSSIN HONEY MAXIMUM STRENGTH COUGH AND CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8756
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
HONEY (UNII: Y9H1V576FH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8756-121 in 1 CARTON06/25/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0031-8756-181 in 1 CARTON06/25/2018
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/25/2018
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 12/2020
Document Id: 9f276740-e9aa-4175-b02d-080307829cca
Set id: eaa10aed-5b1e-48bf-bc05-7a5638851daf
Version: 4
Effective Time: 20201216
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC