TOPCARE CHEST CONGESTION AND COUGH RELIEF DM- dextromethorphan hydrobromide / guaifenesin tablet

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient - (per tablet)

Dextromethorphan Hydrobromide   20mg   Cough Suppressant
Guaifenesin  400mg  Expectorant

ASK DOCTOR

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 (mucous)

STOP USE

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

DO NOT USE

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children, In  ase of overdose, get medical help or contact a Poison Center immediately

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

Directions        
Adults and children 12 years of age and over:    
take 1 tablet every 4 hours as needed    
Children 610 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)     Rev 10/U9 RCCF

INDICATIONS & USAGE

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

PURPOSE

Purpose

Cough Suppressant

Expectorant

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.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

TOPCARE CHEST CONGESTION AND COUGH RELIEF  DM
dextromethorphan hydrobromide / guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-988
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
COPOVIDONE (UNII: D9C330MD8B)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STEARIC ACID (UNII: 4ELV7Z65AP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-988-50	1 in 1 CARTON	01/28/2010
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/07/2009

Labeler - TOPCO ASSOCIATES LLC (006935977)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Reese Pharmaceutical Co		004172052	relabel(36800-988) , repack(36800-988)