Label: LOW DOSE ASPIRIN- aspirin tablet, chewable
- NDC Code(s): 64092-150-36
- Packager: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
- 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 June 13, 2023
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 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
- you have asthma
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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
- vomit blood
- 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.
-
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
-
do not take more than directed
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Healthcare™
NDC 64092-150-36
81 mg LOW STRENGTH
Low Dose Aspirin
Chewable Tablets
Pain Reliever (NSAID)Chew or crush tablets completely
before swallowing.For Aspirin Regimen Users**
For Minor Aches and Pains
Orange FlavoredActual Size
†Compare to the active
ingredient in St. Joseph®
81 mg Chewable AspirinTAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING**Talk to your doctor or other healthcare
provider before using this product for
your heart.†This product is not manufactured or distributed by
Foundation Consumer Healthcare, LLC, owner of the
registered trademark St. Joseph® 81 mg Chewable Aspirin.
Distributed by: Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E., Grand Rapids, MI 49512
www.glwholesale.com50844 REV0122A21807
HEALTHCARE GUARANTEE
If you are not completely satisfied with this
product, regardless of reason, return your unused
portion to Great Lakes Wholesale for a full refund
Healthcare 44-218A
-
INGREDIENTS AND APPEARANCE
LOW DOSE ASPIRIN
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64092-150 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:64092-150-36 1 in 1 CARTON 09/12/1990 09/20/2024 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 not final part343 09/12/1990 09/20/2024 Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(64092-150) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(64092-150) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(64092-150) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(64092-150) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(64092-150)