NDC | 37205-196-68 |
Set ID | abd781d2-b94c-4527-91a9-5abf7bd875de |
Category | HUMAN OTC DRUG LABEL |
Packager | Cardinal Health Inc. |
Generic Name | |
Product Class | Anti-coagulant |
Product Number | |
Application Number | PART343 |
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ACTIVE INGREDIENT
Active Ingredients (in each effervescent tablet) Purpose
Aspirin 325mg NSAID* ............................................. Pain Reliever
Citric Acid 1000 mg ................................................... Antacid
Sodium Bicarbonate (heat-treated) 1916 mg ................ Antacid*Nonsteroidal anti-inflammatory drug
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WARNINGS
Warnings
Reye's syndrome: Children and teenagers should not use this drug 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 casue a sever allergic reaction which may include: - hives - facial swelling - asthma (wheezing) - shock
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you - are age 60 or older - have had stomach ulcers or bleeding problems - take a blood thinning (anticoagulant) or steroid drug - take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) - have 3 or more alcoholic drinks every day while using this product - take more or for a longer time than directed.
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.
- INDICATIONS & USAGE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
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STOP USE
Stop use and ask a doctor if - you experience any of the following signs of stomach bleeding - feel faint - vomit blood - have bloody or black stools - have stomach pain that does not get better - an allergic reaction occurs. Seek medical help right away. - pain lasts for more than 10 days or gets worse - new symptoms occur - redness or swelling is present - ringing in the ears or a loss of hearing occurs
- WHEN USING
- PURPOSE
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DOSAGE & ADMINISTRATION
Directions
- do not exceed recommended dosage
- to avoid serious injury, completely dissolve tablets in 4 oz. of water before takingadults and children 12 years and over
(up to 60 years of age)2 tablets every 4 hours
do not esceed 8 tablets in 24 hours60 year and over
2 tablets every 4 hours
do not exceed 4 tablets in 24 hours - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EFFERVESCENT ANTACID AND PAIN RELIEF
aspirin, sodium bicarbonate, citric acid tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-196 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) BICARBONATE ION 1916 mg ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1000 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor Imprint Code L421 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-196-68 36 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 12/01/2006 Labeler - Cardinal Health Inc. (097537435) Registrant - United Exchange Corporation (840130579) Establishment Name Address ID/FEI Business Operations Tower Laboratories Ltd 869024500 manufacture(37205-196)