Label: ASPIRIN LOW DOSE- aspirin tablet, chewable
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- NDC Code(s): 41163-918-07, 41163-918-99
- Packager: United Natural Foods, Inc. dba UNFI
- 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 August 23, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each chewable 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
- shock
- asthma (wheezing)
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
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- 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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
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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?
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Principal Display Panel
EQUALINE®
compare to Bayer®
Chewable Low Dose Aspirin
active ingredient**
NDC 41163-918-07low dose
aspirin 81 mg
chewable tablets
pain reliever (NSAID)orange flavor
• aspirin regimen
36 chewable tablets
actual size
TALK TO YOUR DOCTOR OR OTHER HEALTHCARE PROVIDER BEFORE USING THIS PRODUCT
FOR YOUR HEART. CHEW OR CRUSH TABLETS COMPLETELY BEFORE SWALLOWING.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 REV0122B21807DISTRIBUTED BY UNFI
PROVIDENCE, RI 02908 USA
855-423-2630100% Quality GUARANTEED
Equaline 44-218
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INGREDIENTS AND APPEARANCE
ASPIRIN LOW DOSE
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-918 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) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color orange Score no score Shape ROUND Size 8mm Flavor ORANGE Imprint Code 44;218 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-918-07 1 in 1 CARTON 09/12/1990 1 36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:41163-918-99 3 in 1 CARTON 09/12/1990 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 09/12/1990 Labeler - United Natural Foods, Inc. dba UNFI (943556183) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(41163-918) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(41163-918) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(41163-918) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(41163-918) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(41163-918)