Robitussin Chest Congestion (guaifenesin)

ROBITUSSIN CHEST CONGESTION- guaifenesin liquid 
Richmond Division of Wyeth

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

ACTIVE INGREDIENT (IN EACH 5 ML TSP)

Guaifenesin, USP 100 mg

PURPOSE

Expectorant

USE

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

WARNINGS

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
  • this adult product is not intended for use in children under 12 years of age
agedose
adults and children 12 years and over2-4 teaspoons every 4 hours
children under 12 yearsdo not use

OTHER INFORMATION

  • each teaspoon contains: sodium 2 mg
  • store at 20-25°C (68-77°F)
  • alcohol-free
  • dosage cup provided

INACTIVE INGREDIENTS

anhydrous citric acid, artificial flavor, caramel, FD&C red no. 40, glycerin, high fructose corn syrup, liquid glucose, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

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.

See New Dosing Information

Adult

Robitussin Chest Congestion

GUAIFENESIN, USP (Expectorant)

NON-DROWSY

RELIEVES:

Chest Congestion/Mucus

For Ages 12 & Over

Alcohol-Free

4 FL OZ (118 mL)

Robitussin Knows

Choosing the right product is important. Robitussin has different products for adults and for children.

GREEN Boxes

Ages 12 & Over

RED Boxes

Ages Under 12

Use as directed

DOSAGE CUP INCLUDED

Wyeth Consumer Healthcare

Madison, NJ 07940 U.S.A.

©2009 Wyeth

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

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

Robitussin Chest Congestion Packaging
ROBITUSSIN CHEST CONGESTION 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8624
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
CARAMEL 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
DEXTROSE 
MENTHOL 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
Product Characteristics
ColorRED (deep wine-colored syrupy liquid) Score    
ShapeSize
FlavorRASPBERRY (raspberry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8624-131 in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:0031-8624-211 in 1 CARTON
2237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/21/200402/28/2013
Labeler - Richmond Division of Wyeth (829390835)

Revised: 12/2012
Document Id: 05c29eaf-5c8e-4688-8d24-37df93b50a71
Set id: 931539cf-9c49-700d-78f7-89046ef666cd
Version: 4
Effective Time: 20121218
 
Richmond Division of Wyeth