OTC Medication Information: Robitussin Direct Chest Congestion

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

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 tabletsRobitussin Direct Chest Congestion 18 tablets
ROBITUSSIN DIRECT CHEST CONGESTION
guaifenesin tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-9303
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
Product Characteristics
Color blue Score 2 pieces
Shape ROUND Size 13mm
Flavor Imprint Code 44;532
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0031-9303-01 18 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 07/15/2022
Labeler — Haleon US Holdings LLC (079944263)

Revised: 03/2024 Haleon US Holdings LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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