Label: ASPIRIN REGULAR STRENGTH- aspirin tablet, coated
- NDC Code(s): 0536-1232-01
- Packager: Rugby Laboratories
- 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.
Updated June 23, 2021
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- Active ingredient (in each tablet)
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
- 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
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.
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- Other information
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?
Principal display panel
Compare to the active ingredient in Ecotrin® regular strength†
Pain Reliever (NSAID)
100 Enteric Coated Tablets
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
††Talk to your doctor or other healthcare provider before using
this product for your heart.
†This product is not manufactured or distributed by Medtech
Products Inc., owner of the registered trademark Ecotrin® Regular Strength.
Distributed by: RUGBY® LABORATORIES,
Livonia, MI 48152
INGREDIENTS AND APPEARANCE
ASPIRIN REGULAR STRENGTH
aspirin tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) 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:0536-1232-01 1 in 1 CARTON 06/01/2019 1 100 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 06/01/2019 Labeler - Rugby Laboratories (079246066) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(0536-1232) , pack(0536-1232) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(0536-1232) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(0536-1232) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(0536-1232)