Label: ASPIRIN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 21695-666-00, 21695-666-30, 21695-666-90 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 57896-401
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 17, 2011
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- 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 or 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) or 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 or 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 if 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, or 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.
- Directions
- Other Information
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Inactive ingredients
May contain acetylated monoglycerides, cellulose, croscarmellose sodium, D&C yellow no. 10, FD&C yellow no. 6, hypromellose, hypromellose phthalate, iron oxide, methacrylic acid, mineral oil, PEG, polydextrose, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica sodium alginate, sodium bicarbonate, sodium lauryl sulfate, starch stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax.
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-666(NDC:57896-401) 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 CELLULOSE ACETATE (UNII: 3J2P07GVB6) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR) FERRIC OXIDE RED (UNII: 1K09F3G675) METHACRYLIC ACID (UNII: 1CS02G8656) MINERAL OIL (UNII: T5L8T28FGP) POLYDEXTROSE (UNII: VH2XOU12IE) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) WHITE WAX (UNII: 7G1J5DA97F) Product Characteristics Color ORANGE Score no score Shape ROUND Size 12mm Flavor Imprint Code T Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-666-30 30 in 1 BOTTLE 2 NDC:21695-666-90 90 in 1 BOTTLE 3 NDC:21695-666-00 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 11/07/2008 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK