TOPCARE TAB TUSSIN DM- dextromethorphan hydrobromide / guaifenesin tablet 
TOPCO ASSOCIATES LLC

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 TOPCARE Tab Tussin DM

Active ingredient - (per tablet)

Dextromethorphan Hydrobromide   20mg   Cough Suppressant

Guaifenesin  400mg  Expectorant

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 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,

In case of overdose, get medical help or contact a Poison Center immediately

Pregnant or breastfeeding

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

Inactive ingredients

magnesium stearate, maltodextrin, microcrystalline cellulose, povidone K30, povidone 90F, silicon dioxide, stearic acid.

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

Uses

Purpose

Cough Suppressant

Expectorant

Warning

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.

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TOPCARE TAB TUSSIN  DM
dextromethorphan hydrobromide / guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-442
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POVIDONE K30 (UNII: U725QWY32X)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint Code PH073
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-442-242 in 1 CARTON05/06/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/06/2021
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Reese Pharmaceutical Co004172052relabel(36800-442) , repack(36800-442)

Revised: 5/2021
Document Id: aef89742-077f-4504-a26a-c3d546cefd5f
Set id: 89df0de0-cc40-4e0e-bad0-5eb66e187471
Version: 2
Effective Time: 20210506
 
TOPCO ASSOCIATES LLC