![LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.]](https://medic.hrt.org//dailymed/images/a0b11f2c-6891-45a1-992b-96cacc420da3/healthcare-44-218-sj-1.jpg)
| NDC | 64092-150-36 |
| Set ID | a0b11f2c-6891-45a1-992b-96cacc420da3 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- 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
- 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 a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- 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.
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Directions
- 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
HEALTHCARE™
NDC 64092-150-36
81 mg LOW STRENGTH
Low Dose Aspirin
Chewable Tablets
Pain Reliever (NSAID)For Aspirin Regimen Users**
For Minor Aches and Pains
Orange FlavoredChew or crush tablets completely before swallowing.
†Compare to the active ingredient in St. Joseph® 81 mg Chewable Aspirin
36 CHEWABLE TABLETS
TAMPER 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.com 50844 ORG111821807HEALTHCARE 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
44-218A
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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 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 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. 832867894 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. 868734088 PACK(64092-150)