Label: ASPIRIN 81- aspirin tablet
- NDC Code(s): 57237-302-10, 57237-302-12
- Packager: Rising Health, LLC
- 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 October 18, 2022
If you are a consumer or patient please visit this version.
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- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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 • asthma (wheezing) • shock
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
• 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
• take more or for a longer time than directed
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 are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if you are taking a prescription drug for gout, diabetes or 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:
●feel faint ● vomit blood ● have bloody or black stools ● have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- ringing in the ears or a loss of hearing occurs
- redness or swelling is present
- new symptoms occur. These could be signs of a serious condition.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN 81
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57237-302 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) METHACRYLIC ACID (UNII: 1CS02G8656) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code I1;Plain Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57237-302-12 120 in 1 BOTTLE; Type 0: Not a Combination Product 10/25/2022 2 NDC:57237-302-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/25/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 10/25/2022 Labeler - Rising Health, LLC (080500961) Establishment Name Address ID/FEI Business Operations Invahealth Inc. 116840615 manufacture(57237-302) , analysis(57237-302) , label(57237-302) , pack(57237-302)
