Label: ASPIRIN REGULAR STRENGTH- aspirin tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 70518-2684-0 - Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 0536-1232
- Category: HUMAN OTC DRUG LABEL
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 September 27, 2021
If you are a healthcare professional or from the pharmaceutical industry 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:
- facial swelling
- hives
- shock
- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
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 asthma
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- diabetes
- arthritis
- gout
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:
- vomit blood
- feel faint
- have bloody or black stools
- have stomach pain that does not get better
- ringing in the ears or a loss of hearing occurs
- new symptoms occur
- pain gets worse or lasts more than 10 days
- redness or swelling is present
These could be signs of a serious condition.
- Directions
- Other information
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Inactive ingredients
black iron oxide, cellulose, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
DRUG: AspirinRegular Strength Regular Strength
GENERIC: Aspirin
DOSAGE: TABLET, COATED
ADMINSTRATION: ORAL
NDC: 70518-2684-0
COLOR: orange
SHAPE: ROUND
SCORE: No score
SIZE: 10 mm
IMPRINT: 44;227
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- ASPIRIN 325mg in 1
INACTIVE INGREDIENT(S):
- SHELLAC
- DIMETHICONE
- TRIETHYL CITRATE
- TRIACETIN
- TITANIUM DIOXIDE
- TALC
- STEARIC ACID
- SODIUM BICARBONATE
- SODIUM ALGINATE
- WATER
- POWDERED CELLULOSE
- Polyvinyl Acetate Phthalate
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYDEXTROSE
- HYPROMELLOSE, UNSPECIFIED
- FD&C YELLOW NO. 6
- D&C YELLOW NO. 10 ALUMINUM LAKE
- STARCH, CORN
- SILICON DIOXIDE
- PROPYLENE GLYCOL
- FERROSOFERRIC OXIDE
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INGREDIENTS AND APPEARANCE
ASPIRIN REGULAR STRENGTH
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-2684(NDC:0536-1232) 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM BICARBONATE (UNII: 8MDF5V39QO) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POWDERED CELLULOSE (UNII: SMD1X3XO9M) Product Characteristics Color orange Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;227 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70518-2684-0 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 04/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/10/2020 Labeler - REMEDYREPACK INC. (829572556)