SIMPEX GUAIFENESIN- guaifenesin tablet

SIMPEX Guaifenesin by

Drug Labeling and Warnings

SIMPEX Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Simpex Pharma Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

SIMPEX GUAIFENESIN  
guaifenesin tablet

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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/09/2018

Labeler - Simpex Pharma Pvt. Ltd (916758275)

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