Guaifenesin Tablets, 400 mg

Guaifenesin by

Drug Labeling and Warnings

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

Drug Details [pdf]

GUAIFENESIN- guaifenesin tablet 
Cardinal Health

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 Tablets, 400 mg

Active ingredient

Guaifenesin, 400 mg

Purpose

Expectorant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • helps 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 is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

  • symptoms are accompanied by fever, rash or persistent headache
  • cough persists for more than 1 week or tends to recur

A persistent cough may be a sign of a serious condition.

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 immediately (1-800-222-1222).

Directions

  • Adults and children 12 years and over: take 1 tablet every 4 hours as needed
  • Children 6 to under 12 years: take 1/2 tablet every 4 hours as needed
  • Children under 6 years: consult a doctor

Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

Other information

  • store at 15°-30°C (59°-86°F)

Inactive ingredients

colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, sodium starch glycolate

Questions or comments?

1-888-341-9214

Package/Label Principal Display Panel

NDC: 70000-0106-1

Expectorant

Guaifenesin, 400 mg

50 TabletsGuaifenesin 400mg 50ct_Carton.jpg

GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70000-0106
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)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeCAPSULESize18mm
FlavorImprint Code YH018
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70000-0106-11 in 1 CARTON08/15/201601/31/2020
150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/15/201601/31/2020
Labeler - Cardinal Health (097537435)

Revised: 2/2020
Document Id: 156e3fd0-50bc-4700-a852-a5af41417d52
Set id: 256a3e24-0d6c-22c2-e054-00144ff88e88
Version: 2
Effective Time: 20200205
 
Cardinal Health