TABCIN 500- acetylsalicylic acid, phenylephrine bitartrate, chlorpheniramine maleate tablet, effervescent

TABCIN by

Drug Labeling and Warnings

TABCIN by is a Otc medication manufactured, distributed, or labeled by Salimex, S.A., Bayer de Mexico, S.A. de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each tablet)

Acetylsalicylic Acid 500 mg
Phenylephrine Bitartrate 8 mg
Chlorpheniramine maleate 2 mg

Purpose

Acetylsalicylic Acid 500 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:

• heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains
• upset stomach with headache from overindulgence in food or drink
• headache, body aches, and pain alone

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:

• hives
• asthma (wheezing)

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

• fully dissolve 2 tablets in 4 ounces of water before taking
• adults and children 12 years and over: 2 tablets every 4 hours, or as directed by a doctor do not exceed 8 tablets in 24 hours
• adults 60 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 4 tablets in 24 hours
• children under 12 years consult a doctor

Other information

• each tablet contains: sodium 567 mg
• store at room temperature. Avoid excessive heat.
• Tabcin 500 in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive ingredients

Sodium Bicarbonate

Questions or comments?

01 800-706-0300

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TABCIN  500
acetylsalicylic acid, phenylephrine bitartrate, chlorpheniramine maleate tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53666-408
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	500 mg
Phenylephrine Bitartrate (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV)	Phenylephrine Bitartrate	8 mg
Chlorpheniramine maleate (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	Chlorpheniramine maleate	2 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	14mm
Flavor		Imprint Code	tabcin
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53666-408-15	150 in 1 CASE
1	NDC: 53666-408-12	12 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/21/2013

Labeler - Salimex, S.A. (589201581)

Establishment
Name	Address	ID/FEI	Business Operations
Bayer de Mexico, S.A. de CV		588165709	manufacture(53666-408)