Leader TabTussin DM TDM

Dosage form: tablet
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg, Guaifenesin 400mg
Labeler: Cardinal Health
NDC Code: 37205-675

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)

Dextromethorphan Hydrobromide   20mg
 
Guaifenesin  400mg

Purpose

Cough Suppressant

Expectorant

Uses

■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
■ Helps make coughs more productive.

Warnings

Do not use  ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.

Ask doctor before use if you have
■ persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma
■ 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 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 DM  TDM
dextromethorphan hydrobromide / guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-675
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
Guaifenesin (Guaifenesin) Guaifenesin400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MALTODEXTRIN 
STEARIC ACID 
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint CodePH073
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-675-6212 TABLET (TABLET) in 1 BLISTER PACK
2NDC:37205-675-012 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(37205-675), repack(37205-675)
Establishment
NameAddressID/FEIOperations
Pharbest557054835manufacture(37205-675)

Revised: 09/2012
 
Cardinal Health

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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