ROBITUSSIN DIRECT CHEST CONGESTION- guaifenesin tablet, coated

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]

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Guaifenesin 400 mg

PURPOSE

Purpose

Expectorant

INDICATIONS & USAGE

Use

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

• store at 20°-25°C (68°-77°F)

INACTIVE INGREDIENT

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

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

INGREDIENTS AND APPEARANCE

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)