Guaifenesin by AvKARE, Inc. Guaifenesin

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by AvKARE, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GUAIFENESIN- guaifenesin tablet 
AvKARE, Inc.

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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Guaifenesin

Active ingredient (in each immediate-release tablet)

Guaifenesin 200 mg

Purpose

Expectorant

Uses

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

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 too much phlegm (mucus)

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.  These could be signs of a serious illness.

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 right away.

Directions

• do not exceed 6 doses in 24 hours
• take with a full glass of water

• adults and children 12 years of age and over: 1 to 2 tablets every ; 4 hours
• children 6 to under 12 years of age:

  ½ to 1 tablet every

  4 hours

• children under 6 years of age: consult a physician

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• use by expiration date on package

Inactive ingredients

FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid

Questions or comments?1-855-361-3993

Principal Display Panel

AvKARE

NDC 42291-313-01

Immediate-Release
GUAIFENESIN
EXPECTORANT
Relieves Chest Congestion
Thins and Loosens Mucus
200 mg

100 Tablets

50844    ORG081258812
Distributed by AvKARE
Pulaski, TN 38478        AV 10/13

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

GUAIFENESIN 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42291-313
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

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

Product Characteristics
Color	pink (dark)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;588
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42291-313-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/04/2013	03/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/04/2013	03/13/2020

Labeler - AvKARE, Inc. (796560394)

Revised: 3/2020

Document Id: a0bf1958-6dec-66b2-e053-2995a90a3b8c

34390-5

Set id: d38eed2d-1df8-84d4-aa6e-0fc98f0a5be9

Version: 5

Effective Time: 20200313

 

AvKARE, Inc.