NDC | 53666-444-12 |
Set ID | 2e946175-5aaa-4cf2-bf71-680d591dc434 |
Category | HUMAN OTC DRUG LABEL |
Packager | Salimex, S.A. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART343 |
- Active Ingredients (in each tablet)
- Keep out of reach of children
- Uses for the relief of:
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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.
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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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TABCIN 500
aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53666-444 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:53666-444-12 12 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 08/21/2013 Labeler - Salimex, S.A. (589201581) Establishment Name Address ID/FEI Business Operations Bayer de Mexico, S.A. de CV 588165709 manufacture(53666-444)