Label: BUFFERIN REGULAR STRENGTH PAIN RELIEF- aspirin tablet, coated
- NDC Code(s): 50066-610-13, 50066-610-30
- Packager: Genomma Lab USA
- 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 May 18, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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
- shock
- facial swelling
- asthma (wheezing)
Stomach bleeding warning
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- 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 asthma
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
- 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
- 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
- have bloody or black stools
- vomit blood
- 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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 325 mg Table Bottle Carton
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INGREDIENTS AND APPEARANCE
BUFFERIN REGULAR STRENGTH PAIN RELIEF
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-610 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 calcium carbonate (UNII: H0G9379FGK) magnesium carbonate (UNII: 0E53J927NA) magnesium oxide (UNII: 3A3U0GI71G) anhydrous citric acid (UNII: XF417D3PSL) Propylene glycol (UNII: 6DC9Q167V3) microcrystalline cellulose (UNII: OP1R32D61U) Product Characteristics Color WHITE Score no score Shape ROUND Size 9mm Flavor Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-610-13 1 in 1 CARTON 05/17/2021 1 130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:50066-610-30 1 in 1 CARTON 05/17/2021 2 30 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 05/17/2021 Labeler - Genomma Lab USA (832323534)
