Guaifenesin by Innovida Pharmaeutique Corporation

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Innovida Pharmaeutique Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GUAIFENESIN- guaifenesin tablet 
Innovida Pharmaeutique Corporation

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Active Ingredient ( in each tablet)

Guaifenesin 400mg

Purpose

Expectorant

Uses

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

Warnings

Ask doctor before use ifyou have
persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
cough is accompanied by excessive phlegm (mucus)
Stop use and ask doctor if
Symptoms are accompanied by fever, rash or persistent headache
cough persists for more than 1 week or tends to recur
A persistent cough may be a sign 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 immediately.

Directions

Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed
Children under 6 years of age: consult a doctor

Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other information

store at 15°-30°C (59°-86°F)

Inactive Ingredients

magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

Questions or Comments? 1-888-462-4166

Product label

GUAIFENESIN 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71800-049
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
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71800-049-06	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/10/2025	12/31/2025

Labeler - Innovida Pharmaeutique Corporation (080892908)

Revised: 12/2025

Document Id: 46e119c4-d3aa-eefc-e063-6294a90a94f1

34390-5

Set id: e2889673-a8aa-4cb1-ba52-fb94b7b057ab

Version: 2

Effective Time: 20251226