Leader TabTussin DM by Cardinal Health / Reese Pharmaceutical Co / Pharbest DRUG FACTS

Drug Details [pdf]

LEADER TABTUSSIN DM TDM- dextromethorphan hydrobromide / 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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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.

image of display

LEADER TABTUSSIN DM TDM
dextromethorphan hydrobromide / guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-675
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	400 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	PH073
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 37205-675-01	2 in 1 CARTON	08/01/2012	02/28/2019
1	NDC: 37205-675-62	12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/01/2012	02/28/2019

Labeler - Cardinal Health (097537435)

Registrant - Reese Pharmaceutical Co (004172052)

Name	Address	ID/FEI	Business Operations
Establishment
Reese Pharmaceutical Co		004172052	relabel(37205-675) , repack(37205-675)

Name	Address	ID/FEI	Business Operations
Establishment
Pharbest		557054835	manufacture(37205-675)

Revised: 2/2020

Document Id: c5ce4009-9ce9-4d6b-93eb-6a2245cc3175

Set id: 277ef76d-62f1-4114-b229-b0d2570366e1

Version: 2

Effective Time: 20200219

Cardinal Health