Label: CHEWABLE ADULT LOW DOSE ASPIRIN- aspirin tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 68163-081-91 - Packager: Raritan Pharmaceuticals Inc
- 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 8, 2021
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:
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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 over
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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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- this product 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 are taking a diuretic
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- you have asthma
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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- redness or swelling is present
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- new symptoms occur
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- ringing in the ears or loss of hearing occurs
These could be signs of a serious condition
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery
- Directions
- Other information
- Inactive ingredients
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Principal Display Panel
DRxChoice
compare to Bayer® Chewable Low Dose Aspirin active ingredients**
NDC 68163-081-91
low dose
CHEWABLE ASPIRIN
81 mg tabletspain reliever (NSAID)
orange flavor
aspirin regimen36 Chewable Tablets
3 bottles - 36 tablets each
value pack
DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING
**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Chewable Low Dose Aspirin.
GLUTEN-FREE (less than 20ppm gluten. If you have specific dietary needs you should consult a doctor before consuming this product.
Distributed By:
Raritan Pharmaceuticals Inc
8 Joanna Court
ASPIRIN Display artwork-1
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INGREDIENTS AND APPEARANCE
CHEWABLE ADULT LOW DOSE ASPIRIN
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-081 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 DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) STARCH, CORN (UNII: O8232NY3SJ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color ORANGE Score no score Shape ROUND Size 8mm Flavor ORANGE Imprint Code RP81 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68163-081-91 3 in 1 CARTON 06/03/2013 1 36 in 1 BOTTLE, PLASTIC; 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 06/03/2013 Labeler - Raritan Pharmaceuticals Inc (127602287)
