ROBITUSSIN DIRECT CHEST CONGESTION- guaifenesin tablet, coated 
Haleon US Holdings LLC

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Drug Facts

Active ingredient (in each tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Use

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Ask a doctor before use if you have

•
cough accompanied by too much phlegm (mucus)
•
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a 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

•
take with a full glass of water
•
do not take more than 6 tablets in 24 hours
•
do not take more than directed

adults and children 12 years and over

take 1 tablet every 4 hours

children under 12 years

Do not use

Other information

•
store at 20°-25°C (68°-77°F)

Inactive ingredients

FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

Call weekdays from 9 AM-5 PM EST at 1-800-245-1040

Additional Information

Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.

Lift Here for More Drug Facts

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

visit www.robitussin.com

Trademarks owned or licensed by GSK.

©2022 GSK or licensor.

Made in China

PRINCIPAL DISPLAY PANEL

NEW

Robitussin

Chest Congestion

Guaifenesin
(Expectorant)

direct

Actual size

18
Tablets
L-0630-532-44-UPC_ORG Front Label

Robitussin Direct Chest Congestion 18 tablets
ROBITUSSIN DIRECT CHEST CONGESTION 
guaifenesin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-9303
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code 44;532
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-9303-0118 in 1 BOTTLE; Type 0: Not a Combination Product07/15/202202/15/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/15/202202/15/2025
Labeler - Haleon US Holdings LLC (079944263)

Revised: 4/2024
Document Id: 7913f832-10b1-45e8-bc2e-8fc1ae59d817
Set id: 5998b7dd-e376-4ea7-955e-707268e12b0b
Version: 7
Effective Time: 20240412
 
Haleon US Holdings LLC