Label: ASPIRIN tablet, film coated
- NDC Code(s): 82804-167-60
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0536-1054
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 1, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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:
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- shock
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- facial swelling
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- hives
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- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
Do not use
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- if you are allergic to aspirin or any other pain reliever/fever reducer
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- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
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- stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- you have asthma
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- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
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- gout
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- diabetes
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- arthritis
Stop use and ask a doctor if
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- an allergic reaction occurs. Seek medical help right away.
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- ringing in the ears or a loss of hearing occurs
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- pain gets worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
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- new symptoms occur
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- redness or swelling is present
These could be signs of a serious condition.
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Directions
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do not take more than directed
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- drink a full glass of water with each dose
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- adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
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- 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
Rugby®
NDC 82804-167-60
†Compare to the active ingredient in
Genuine Bayer® AspirinAspirin
325 mg
Pain Reliever / Fever Reducer
(NSAID)Safe Pain Relief
Actual size
60 Tablets†This product is not manufactured or distributed by Bayer AG, owner of the registered trademark Genuine Bayer® Aspirin.
50844 REV0122D15712Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL AROUND CAP IS BROKEN OR MISSINGRev. 09/20 R-17 Re-order No. 370397
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INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82804-167(NDC:0536-1054) 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;157;ASPIRIN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82804-167-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/27/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 02/10/1996 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(82804-167) , RELABEL(82804-167)
