Label: TRI-BUFFERED ASPIRIN- aspirin tablet, film coated
- NDC Code(s): 71205-517-30, 71205-517-60, 71205-517-90
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0904-2015
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 1, 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 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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- hives
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- facial swelling
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- shock
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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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- have had stomach ulcers or bleeding problems
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- have 3 or more alcoholic drinks every day while using this product
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- are age 60 or older
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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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- 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 are taking a diuretic
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- 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
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- gout
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- arthritis
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- diabetes
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:
- o
- feel faint
- o
- vomit blood
- o
- have bloody or black stools
- o
- 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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- redness or swelling is present
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- new symptoms occur
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
NDC 71205-517-30
Compare to the active ingredient in BUFFERIN®†
TRI-BUFFERED
ASPIRIN
325 mgpain reliever/fever reducer (NSAID)
30 TABLETS
†This product is not manufactured or distributed by Dr. Reddy's Laboratories Inc., owner of the registered trademark Bufferin®.
50844 REV0318M18312Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USARepackaged by Proficient Rx LP
Thousand Oaks, CA 91320
M-17
Re-order No. 700594 Rev. 07/18TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
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INGREDIENTS AND APPEARANCE
TRI-BUFFERED ASPIRIN
aspirin tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-517(NDC:0904-2015) 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) DIMETHICONE 410 (UNII: TYU5GP6XGE) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) STARCH, CORN (UNII: O8232NY3SJ) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code 44;183 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-517-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2020 2 NDC:71205-517-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2020 3 NDC:71205-517-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/30/1990 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(71205-517) , RELABEL(71205-517)
