Label: ASPIRIN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 49638-481-36 - Packager: America Medic & Science
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 18, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
- OTHER SAFETY INFORMATION
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SPL UNCLASSIFIED SECTION
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 steriod drug
- take other drugs containing prescription or non-prescription 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
- DO NOT USE
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ASK DOCTOR
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
- you have not been drinking fluids
- you have lost a lot of fluid due to vomiting or diarrhea
- ASK DOCTOR/PHARMACIST
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STOP USE
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- 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
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- new symptoms occur
- ringing in the ear or loss of hearing occurs
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- INACTIVE INGREDIENT
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49638-481 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARNAUBA WAX (UNII: R12CBM0EIZ) BROWN IRON OXIDE (UNII: 1N032N7MFO) DIMETHICONE (UNII: 92RU3N3Y1O) Product Characteristics Color yellow Score no score Shape ROUND Size 8mm Flavor Imprint Code AP;121 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49638-481-36 365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/18/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 01/18/2017 Labeler - America Medic & Science (071065464) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC 037052099 manufacture(49638-481)