Label: ASPIRIN LOW DOSE CHEWABLE ORANGE- aspirin tablet, chewable
- NDC Code(s): 55154-2635-0
- Packager: Cardinal Health 107, LLC
- This is a repackaged label.
- Source NDC Code(s): 0904-6794
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 25, 2024
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- 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
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
Do not use
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- if you are allergic to aspirin or any other pain reliever/fever reducer
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- for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
Ask a doctor before use if
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- stomach bleeding warning applies to you
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- you have a history of stomach problems such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
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- you have asthma
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- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
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- gout
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- diabetes
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- arthritis
Stop use and ask a doctor if
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- an allergic reaction occurs. Seek medical help right away.
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- pain gets worse or lasts more than 10 days
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- fever get worse or lasts more than 3 days
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- redness or swelling is present
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- ringing in the ears or loss of hearing occurs
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- any new symptoms occur
These could be signs of a serious condition
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ASPIRIN LOW DOSE CHEWABLE ORANGE
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-2635(NDC:0904-6794) 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) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color orange Score no score Shape ROUND Size 8mm Flavor Imprint Code PH034 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-2635-0 10 in 1 BAG 06/25/2024 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 Drug M013 06/25/2024 Labeler - Cardinal Health 107, LLC (118546603) Establishment Name Address ID/FEI Business Operations Safecor Health, LLC 828269675 REPACK(55154-2635)
