GUAIFENESIN 400MG- guaifenesin tablet
Medline Industries, LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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987 Guaifenesin 400mg tablet

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

53329-987-62

GUAIFENESIN 400MG
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-987
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
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-987-62	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2018	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/22/2018	12/31/2021

Labeler - Medline Industries, LP (025460908)

Revised: 11/2021

Document Id: d0ebaa5d-81d4-15a6-e053-2995a90a24f3

Set id: 6cd11814-c707-1b74-e053-2991aa0a0619

Version: 4

Effective Time: 20211116

Medline Industries, LP