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

Label 1
Label 2
GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42291-313
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorpink (dark) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;588
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42291-313-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/04/201303/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/04/201303/13/2020
Labeler - AvKARE, Inc. (796560394)

Revised: 3/2020
Document Id: a0bf1958-6dec-66b2-e053-2995a90a3b8c
Set id: d38eed2d-1df8-84d4-aa6e-0fc98f0a5be9
Version: 5
Effective Time: 20200313
 
AvKARE, Inc.