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Leader TabTussin 400 by Cardinal Health

Dosage form: tablet
Ingredients: Guaifenesin 400mg
Labeler: Cardinal Health
NDC Code: 37205-674

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.

Drug Facts


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 doctor before use if you have

  • persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
  • cough is accompanied by excessive phlegm (mucus)

Stop use and ask 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.

Directions
  • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
  • Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed
  • Children under 6 years of age: 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

magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

LEADER TABTUSSIN 400 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-674
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin400 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN 
STEARIC ACID 
SILICON DIOXIDE 
COPOVIDONE 
MAGNESIUM STEARATE 
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint CodePH063
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-674-0112 TABLET (TABLET) in 1 BLISTER PACK
2NDC:37205-674-642 TABLET (BLISTER PACK) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2012
Labeler - Cardinal Health (097537435)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIOperations
Reese Pharmaceutical Co004172052relabel(37205-674), repack(37205-674)
Establishment
NameAddressID/FEIOperations
Pharbest557054835manufacture(37205-674)

Revised: 09/2012
 
Cardinal Health

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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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