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ROBITUSSIN PEAK COLD MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (dextromethorphan hbr, guaifenesin) liquid
[Richmond Division of Wyeth]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TSP)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

PURPOSES

Cough suppressant

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

  • shake well before using
  • do not take more than 6 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
agedose
adults and children 12 years and over2 teaspoons every 4 hours
children under 12 yearsdo not use

OTHER INFORMATION

  • each teaspoon contains: sodium 5 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
  • dosage cup provided

INACTIVE INGREDIENTS

anhydrous citric acid, carboxymethylcellulose sodium, D&C red no. 33, FD&C red no. 40, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose, natural and artificial flavor, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

QUESTIONS OR COMMENTS?

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

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Formerly DM MAX

ADULT

Robitussin PEAK COLD MAXIMUM STRENGTH Cough+Chest Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

Relieves:

  • Cough
  • Mucus

Non-Drowsy

For Ages 12 & Over

4 FL OZ (118 ml)

Find the right product for you with the Robitussin Relief Finder on Robitussin.com

  • at home
  • on your mobile phone

Use dosage cup included

Pfizer, Madison, NJ 07940 USA

© 2011 Pfizer Inc.

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

Droplet is not representative of actual product color.

Should be 18 or older to purchase

PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

Maximum strength claim based on maximum daily dose of active ingredients.

Robitussin Peak Cold Maximum Strength Cough+Chest Congestion DM Packaging

INGREDIENTS & APPEARANCE

ROBITUSSIN PEAK COLD MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0031-8738
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dextromethorphan hydrobromide (dextromethorphan) dextromethorphan hydrobromide10 mg  in 5 mL
guaifenesin (guaifenesin) guaifenesin200 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
carboxymethylcellulose sodium 
D&C red no. 33 
FD&C red no. 40 
glycerin 
high fructose corn syrup 
menthol 
cellulose, microcrystalline 
polyethylene glycol 
povidone 
propylene glycol 
saccharin sodium 
sodium benzoate 
sorbitol 
xanthan gum 
water 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorImprint Code
Contains5 mg sodium (5 mg sodium)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8738-121 in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:0031-8738-181 in 1 CARTON
2237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/15/2011
Labeler - Richmond Division of Wyeth (829390827)
Establishment
NameAddressID/FEIBusiness Operations
Richmond Division of Wyeth829390827MANUFACTURE, ANALYSIS, LABEL, PACK

Revised: 6/2011
 
Richmond Division of Wyeth