Label: REGULAR STRENGTH ENTERIC COATED ASPIRIN - aspirin tablet, coated
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- NDC Code(s): 57896-921-01, 57896-921-10, 57896-921-25, 57896-921-50
- Packager: Geri-Care Pharmaceutical Corp
- 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 November 22, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
- for the temporary relief of minor aches and pains
- ask your doctor about other uses for aspirin
- 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
- 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
CloseKeep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- Directions
- drink a full glass of water with each dose
- swallow whole, do not chew or crush
- do not exceed recommended dose
- adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor
- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
cellulose, D and C yellow #10, FD and C yellow #6, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, shellac wax, silica, simethicone, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate. May also contain: acetylated monoglycerides, croscarmellose sodium, hypromellose phthalate, methacrylic acid, mineral oil, polysorbate 80, sodium lauryl sulfate.
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- package label
GERICARE
NDC 57896-921-01
Regular Strength
ENTERIC COATED ASPIRIN
pain reliever (NSAID)
PACKAGE NOT CHILD RESISTANT
100 Tablets
325 mg each
Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
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- INGREDIENTS AND APPEARANCE
REGULAR STRENGTH ENTERIC COATED ASPIRIN
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM ALGINATE (UNII: C269C4G2ZQ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) DIMETHICONE (UNII: 92RU3N3Y1O) 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:57896-921-01 100 in 1 BOTTLE 2 NDC:57896-921-10 1000 in 1 BOTTLE 3 NDC:57896-921-25 250 in 1 BOTTLE 4 NDC:57896-921-50 500 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 07/01/2000 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254) CloseEstablishment Name Address ID/FEI Business Operations Geri-Care Pharmaceutical Corp 611196254 repack(57896-921)