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

image description

GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71800-049
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize17mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71800-049-0660 in 1 BOTTLE; Type 0: Not a Combination Product02/10/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/10/202512/31/2025
Labeler - Innovida Pharmaeutique Corporation (080892908)

Revised: 12/2025
 
Innovida Pharmaeutique Corporation