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TABCIN

Salimex, S.A.

TABCIN 500


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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

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

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.

  • 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

Sodium Bicarbonate

01 800-706-0300

TABCIN

TABCIN

Acetylsalicylic Acid, Phenylephrine Bitartrate, Chlorpheniramine maleate TABLET, EFFERVESCENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53666-408
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 500 mg
phenylephrine bitartrate PHENYLEPHRINE 8 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM BICARBONATE

Product Characteristics

Color Size Imprint Code Shape
white 14 mm tabcin ROUND

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-08-21


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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