GUAIFENESIN 400MG- guaifenesin tablet

Guaifenesin 400mg by

Drug Labeling and Warnings

Guaifenesin 400mg by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each immediate-release tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

• helps loosen phelgm (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 by excessive phlegm (mucus)

When using this product

• do not exceed recommend dosage
• do not use for more than 7 days

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

ask a healthcare 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 and children 12 years of age and older: take 1 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

• store at 25 degrees Celsius (77 degrees Fahrenheit) excursions permitted between 15 degrees to 30 degrees Celsius (fifty nine degrees to eighty six degrees Fahrenheit)
• keep in a dry place and do not expose to excessive heat

Inactive ingredients

collodial silicon dioxide, magnesium stearate, maltodextrin, microcrystallline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

Call toll free 1-800-MEDLINE (633-5463)

Monday-Friday 9AM-5PM CST

Package Label

INGREDIENTS AND APPEARANCE

GUAIFENESIN 400MG 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-987
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL;272
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-987-62	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/22/2018

Labeler - Medline Industries (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Labs		037052099	manufacture(53329-987) , pack(53329-987)

Establishment
Name	Address	ID/FEI	Business Operations
Medline Industries		079800021	repack(53329-987)