- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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WARNINGS
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.
Stomach Bleeding Warning:This product contains nonsteroidal anti-inflammatory dugs (NSAIDs), which may cause 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 an NSAID (aspirin, ibuprofen, naproxen, or others.
• Take more or for a longer time than directed
Allergy Alert-Do not use:
• if you are allergic to aspirin or any other salicylates
• If you have ever had an allergic reaction to any other pain reliever/fever reducer
Do not use:
• with any other pain reliever/fever reducer
Ask doctor before using if you have:
• upset stomach or stomach pain
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• taken a diuretic
• reached age 60 or olderAsk a doctor or pharmacist before use if you are:
• taking any other drug containing an NSAID (prescription or nonprescription)
• taking a blood thinning (anticoagulant) or steroid drugStop use and ask a doctor if:
• ringing in the ears or loss of hearing occurs
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZEE ASPIRIN
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35418-232 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K29/32 (UNII: 390RMW2PEQ) Product Characteristics Color white (snow white) Score no score Shape ROUND ( FR21) Size 10mm Flavor Imprint Code FR21 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35418-232-68 50 in 1 CARTON 06/12/2012 1 NDC:35418-232-67 125 in 1 CARTON 1 NDC:35418-232-02 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:35418-232-70 24 in 1 BOX 06/12/2012 2 NDC:35418-232-67 125 in 1 CARTON 2 NDC:35418-232-02 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/12/2012 Labeler - Zee Medical Inc (009645623) Registrant - Ultra Seal Corporation (085752004) Establishment Name Address ID/FEI Business Operations Ultratab Laboratories, Inc. 151051757 manufacture(35418-232) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 repack(35418-232)