Label: ASPIRIN tablet, coated
- NDC Code(s): 80425-0293-1, 80425-0293-2, 80425-0293-3
- Packager: Advanced Rx Pharmacy of Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 57896-921
- 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 April 27, 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
- INDICATIONS & USAGE
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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
- facial swelling
- asthma (wheezing)
- shock
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- 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.
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you are taking a diuretic
- you have a history of stomach problems, such as heartburn
- you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma
Ask a doctor or pharmacist before use if you are
- taking any other drug containing an NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant) or steroid drug
- taking a prescription drug for diabetes, gout or arthritis
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding: -feel faint -vomit blood -have bloody or black stools -have stomach pain that does not get better
- an allergic reaction occurs. Seek medical help right away
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- any new symptoms occur
- ringing in the ears or loss of hearing occurs
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
- Directions
- KEEP OUT OF REACH OF CHILDREN
- Other Information
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INACTIVE INGREDIENT
black iron oxide, cellulose, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, hypromellose, polydextrose,
polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, silicon dioxide, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate. - QUESTIONS
- STORAGE AND HANDLING
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STOP USE
Stop use and ask a doctor if
- 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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- ringing in the ears or a loss of hearing occurs
- you experience any of the following signs of stomach bleeding:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80425-0293(NDC:57896-921) 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) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color orange Score no score Shape ROUND Size 9mm Flavor Imprint Code 44;227 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80425-0293-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2023 2 NDC:80425-0293-2 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2023 3 NDC:80425-0293-3 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/27/2023 Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142) Establishment Name Address ID/FEI Business Operations Advanced Rx Pharmacy of Tennessee, LLC 117023142 repack(80425-0293)