ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide, guaifenesin solution

ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM by

Drug Labeling and Warnings

ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, PF Consumer Healthcare Canada ULC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

age	dose
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 12 mg
• store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum

Questions or comments?

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

Made in Canada

For most recent product information, visit www.robitussin.com

SPL UNCLASSIFIED SECTION

Distributed by:
Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

ADULT
Robitussin®

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 Carton

See
New
Dosing

ADULT
Robitussin®

MAXIMUM STRENGTH

Cough+Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

• ✓ Controls Cough
• ✓ Relieves Chest Congestion
• ✓ Thins & Loosens Mucus

Non-Drowsy

BETTER
TASTING!
Same Effective
Cough Relief*

DM
MAX

For Ages 12 & Over

4 FL OZ (118 ml)

INGREDIENTS AND APPEARANCE

ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hydrobromide, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-8739
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRIACETIN (UNII: XHX3C3X673)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8739-12	1 in 1 CARTON	06/01/2016
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0031-8739-18	1 in 1 CARTON	06/01/2016
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0031-8739-42	1 in 1 CARTON	06/01/2016
3		355 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/01/2016

Labeler - Wyeth Consumer Healthcare LLC (828831730)

Establishment
Name	Address	ID/FEI	Business Operations
PF Consumer Healthcare Canada ULC		203812479	ANALYSIS(0031-8739) , LABEL(0031-8739) , MANUFACTURE(0031-8739) , PACK(0031-8739)