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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Drug Facts

Active Ingredient

(in each immediate-release 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.

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 recommended 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°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to excessive heat

Inactive ingredients

Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid

Principal display panel

AvKARE
NDC
42291-312-30

Immediate-release
GUAIFENESIN

EXPECTORANT
• Relieves Chest Congestion
• Thins and Loosens Mucus

400 mg

30 Tablets

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING

Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Lot:
Exp Date:

AV 05/12

label front
label tab
GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42291-312
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg
Inactive Ingredients
Ingredient NameStrength
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Magnesium Stearate (UNII: 70097M6I30)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Povidone (UNII: FZ989GH94E)  
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize12mm
FlavorImprint Code TCL272
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42291-312-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/16/201201/03/2018
2NDC:42291-312-6060 in 1 BOTTLE; Type 0: Not a Combination Product05/16/201201/03/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/16/201201/03/2018
Labeler - AvKARE, Inc. (796560394)

Revised: 1/2018
 
AvKARE, Inc.