Drug Facts

Active ingredient (in each tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

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

Warnings

Ask a doctor before use if you have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied with excessive phlegm (mucus)

Stop use and ask a doctor if

cough lasts more than 7 days, recurs, or is accompanied with fever, rash, or persistent headache.These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care 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

adults & children 12 years of age and older : take a tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
children under 12 years of age : do not use.

Other information

preserve in tight containers at a temperature not exceeding 30°C.

Inactive ingredients

colloidal anhydrous silica, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, pregelatinised starch, sodium starch glycolate type A, stearic acid

Package Labeling:

Label4

SIMPEX GUAIFENESIN
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76457-004
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	red (Iron oxide red, Iron oxide yellow)	Score	no score
Shape	ROUND (Biconvex)	Size	6mm
Flavor		Imprint Code	;
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76457-004-00	100 in 1 CARTON; Type 0: Not a Combination Product	02/09/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	02/09/2018

Labeler - Simpex Pharma Pvt. Ltd (916758275)

Name	Address	ID/FEI	Business Operations
Establishment
Simpex Pharma Pvt. Ltd		916758275	manufacture(76457-004)

SIMPEX Guaifenesin