Label: ASPIRIN CHEWABLE- aspirin 81 mg tablet
- NDC Code(s): 48433-129-01
- Packager: Safecor Health, LLC
- This is a repackaged label.
- Source NDC Code(s): 69168-288
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 28, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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.
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 three (3) or more alcoholic drinks every day while using this
- take more or for a longer time than directed.
- Do not use
- Ask a doctor before use if
- Ask a doctor or pharmacist before use if
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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 stool
- 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
- If pregnant or breast-feeding,
- Keep out of reach of childen.
- Directions
- Other information:
- Inactive ingredients:
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ASPIRIN CHEWABLE
aspirin 81 mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48433-129(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:48433-129-01 100 in 1 BOX 11/01/2022 1 1 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 not final part343 11/01/2022 Labeler - Safecor Health, LLC (828269675) Establishment Name Address ID/FEI Business Operations Safecor Health, LLC 078805287 repack(48433-129) , relabel(48433-129)