Label: PAIN RELIEF ASPIRIN CHEWABLE, LOW DOSE- aspirin tablet, chewable
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- NDC Code(s): 11822-0397-7, 11822-0397-9
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
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 July 1, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
-
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
- shock
- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- 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
- have had stomach ulcers or bleeding problems
- take more or for a longer time than directed
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
- if you have ever had an allergic reaction to this product or any of its ingredients
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 have asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- gout
- diabetes
- arthritis
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:
- vomit blood
- have bloody or black stools
- feel faint
- have stomach pain that does not get better
- ringing in the ears or a loss of hearing occurs
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
-
Directions
- do not take more than directed
- drink a full glass of water with each dose
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- adults and children 12 years and over: take 4 to 8 chewable tablets every 4 hours not to exceed 48 chewable tablets in 24 hours unless directed by a doctor
- children under 12 years: do not use unless directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
NDC 11822-0397-7
Talk to your doctor or other healthcare provider
before using this product for your heart.
**Compare to the active ingredient in
Bayer® Chewable Low Dose AspirinCHEWABLE LOW DOSE
PAIN RELIEF ASPIRIN
ASPIRIN 81 mg
CHEWABLE TABLETS
PAIN RELIEVER (NSAID)Chew or crush tablets
completely before swallowing.
CHERRY FLAVOR
ACTUAL
SIZE36 CHEWABLE TABLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
**This product is not manufactured or distributed by
Bayer AG, owner of the registered trademark Bayer®
Chewable Low Dose Aspirin. 50844 REV0122C39707DISTRIBUTED BY: RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011 www.riteaid.com
SATISFACTION
GUARANTEEIf you're not satisfied, we'll
happily refund your money.
Rite Aid 44-397A
-
INGREDIENTS AND APPEARANCE
PAIN RELIEF ASPIRIN CHEWABLE, LOW DOSE
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0397 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) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) D&C RED NO. 30 (UNII: 2S42T2808B) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color pink (Light Pink) Score no score Shape ROUND Size 8mm Flavor CHERRY Imprint Code 44;397 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0397-7 1 in 1 CARTON 09/04/2001 1 36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:11822-0397-9 3 in 1 CARTON 09/04/2001 2 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 not final part343 09/04/2001 Labeler - Rite Aid Corporation (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(11822-0397) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(11822-0397) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(11822-0397) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(11822-0397) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(11822-0397)