Robitussin Direct Chest Congestion by Haleon US Holdings LLC Drug Facts

Robitussin Direct Chest Congestion by

Drug Labeling and Warnings

Robitussin Direct Chest Congestion by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 
guaifenesin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-9303
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	44;532
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-9303-01	18 in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2022	02/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/15/2022	02/15/2025

Labeler - Haleon US Holdings LLC (079944263)

Revised: 4/2024

Document Id: 7913f832-10b1-45e8-bc2e-8fc1ae59d817

34390-5

Set id: 5998b7dd-e376-4ea7-955e-707268e12b0b

Version: 7

Effective Time: 20240412