ROBITUSSIN MUCUS PLUS 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.

----------

ROBITUSSIN® MUCUS PLUS CHEST CONGESTION

Drug Facts

Active ingredient (in each 10 mL)

Guaifenesin, USP 200 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

agedose
adults and children 12 years and over10-20 ml every 4 hours
children under 12 yearsdo not use

Other information

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

Distributed by:
Pfizer, Madison, NJ 07940 USA

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

ADULT

Robitussin®

Mucus + Chest Congestion

GUAIFENESIN (Expectorant)

Alcohol-Free

4 FL OZ (118 ml)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

ADULT

Robitussin®

Mucus + Chest
Congestion

GUAIFENESIN (Expectorant)

Relieves:

Mucus
Chest Congestion

Alcohol-Free

ORIGINAL

For Ages 12 & Over

4 FL OZ
(118 ml)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
ROBITUSSIN MUCUS PLUS CHEST CONGESTION 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8724
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARAMEL (UNII: T9D99G2B1R)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorRED (deep wine) Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8724-121 in 1 CARTON
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/18/2012
Labeler - Richmond Division of Wyeth (829390835)
Establishment
NameAddressID/FEIBusiness Operations
Fareva Richmond, Inc.969523245ANALYSIS(0031-8724) , LABEL(0031-8724) , MANUFACTURE(0031-8724) , PACK(0031-8724) , RELABEL(0031-8724) , REPACK(0031-8724)

Revised: 3/2015
Document Id: 79db3cc6-0367-4120-9b42-68ff68b0e807
Set id: 259c8b69-c625-4146-b888-34ef43b8385f
Version: 3
Effective Time: 20150327
 
Richmond Division of Wyeth