TABCIN 500- aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescent 
Salimex, S.A.

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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TABCIN

Active Ingredients
(in each tablet)

Acetylsalicylic Acid 324 mg

Phenylephrine Bitartrate 8 mg
Chlorpheniramine maleate 2 mg

Purpose

Acetylsalicylic Acid 324 mg Analgesic
Phenylephrine Bitartrate 8 mg Decongestant
Chlorpheniramine maleate 2 mg Antihistamine

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Uses for the relief of:

Warnings

Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

Directions

Other information

Inactive ingredients

Sodium Bicarbonate

Questions or comments?

01 800-706-0300

image description

TABCIN  500
aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53666-444
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
Phenylephrine Bitartrate (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) Phenylephrine Bitartrate8 mg
Chlorpheniramine maleate (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) Chlorpheniramine maleate2 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize14mm
FlavorImprint Code tabcin
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53666-444-1212 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34308/21/2013
Labeler - Salimex, S.A. (589201581)
Establishment
NameAddressID/FEIBusiness Operations
Bayer de Mexico, S.A. de CV588165709manufacture(53666-444)

Revised: 8/2013
Document Id: d9d0b2bf-f514-4370-92cb-ecba0e49e9ed
Set id: 2e946175-5aaa-4cf2-bf71-680d591dc434
Version: 1
Effective Time: 20130828
 
Salimex, S.A.