Label: PHARBEST REGULAR STRENGTH ASPIRIN- aspirin tablet
- NDC Code(s): 16103-365-08, 16103-365-11
- Packager: Pharbest Pharmaceuticals, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 31, 2024
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- Active ingredient (in each 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
- 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
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- 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 are taking a diuretic
- you have asthma
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 •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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- ringing in the ears or loss of hearing occurs
- new symptoms occur
- Directions
- Other information
- Inactive ingredient
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PHARBEST REGULAR STRENGTH ASPIRIN
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16103-365 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score no score Shape ROUND (ROUND TABLET) Size 10mm Flavor Imprint Code PH033 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16103-365-08 1 in 1 CARTON 01/12/2007 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:16103-365-11 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/12/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/12/2007 Labeler - Pharbest Pharmaceuticals, Inc (557054835) Registrant - Pharbest Pharmaceuticals, Inc (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc 557054835 analysis(16103-365) , manufacture(16103-365) , label(16103-365) , pack(16103-365)