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Guaifenesin by Cardinal Health, Inc.

Dosage form: tablet
Ingredients: GUAIFENESIN 400mg
Labeler: Cardinal Health, Inc.
NDC Code: 70000-0106

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.

Chest Congestion Relief, Guaifenesin Tablets, 400 mg

Active ingredient( per tablet)

Guaifenesin 400mg

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

GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K29/32 
SILICON DIOXIDE 
LACTOSE MONOHYDRATE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
MAGNESIUM STEARATE 
Product Characteristics
Colorwhite (White to off white) Score2 pieces
ShapeCAPSULESize18mm
FlavorImprint CodeYH018
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0106-11 BOTTLE in 1 CARTON
150 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/15/2016
Labeler - Cardinal Health, Inc. (097537435)

Revised: 07/2016
 
Cardinal Health, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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