Label: ASPIRIN CHEWABLE- aspirin 81 mg tablet
- NDC Code(s): 63739-434-01, 63739-434-02
- Packager: McKesson Corporation dba SKY Packaging
- This is a repackaged label.
- Source NDC Code(s): 69168-288
- 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.
Updated March 17, 2021
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- Active ingredient
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.
Allergy alert: Aspirin may cause a severe allergic reaction which may include hives, facial swelling, asthma (wheezing), shock.
Stomach bleeding warning: This product contains an 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
Do not use
if you are allergic to aspirinor any other pain reliever/fever reducer this product for at least 7 days after tonsillectomy or oral surgery unless directed by a 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
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
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
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- Keep Out of Reach of Children
- Inactive Ingredients
- HOW SUPPLIED
- Drug Facts
- Drug Facts
INGREDIENTS AND APPEARANCE
aspirin 81 mg tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63739-434(NDC:69168-288) 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 DEXTRATES (UNII: G263MI44RU) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color orange Score no score Shape ROUND Size 7mm Flavor ORANGE Imprint Code AZ013 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63739-434-01 25 in 1 BOX, UNIT-DOSE 08/02/2016 05/31/2021 1 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63739-434-02 30 in 1 BOX 03/18/2021 2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 12/18/2014 Labeler - McKesson Corporation dba SKY Packaging (140529962) Establishment Name Address ID/FEI Business Operations Legacy Pharmaceutical Packaging, LLC 143213275 repack(63739-434) , relabel(63739-434)