Label: ASPIRIN - aspirin tablet, delayed release
- NDC Code(s): 11534-155-11
- Packager: Sunrise Pharmaceutical Inc
- 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.
Updated January 10, 2011
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- OTC - ACTIVE INGREDIENT
Aspirin 81 mg (NSAID) nonsteroidal anti-inflammatory drugClose
- OTC - PURPOSE
- INDICATIONS AND USAGE
For temporary relief of minor aches and pains or as recommended by your doctor.
Because of its delayed release action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.Close
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.Close
- OTC - ASK DOCTOR
Before use if:
stomach bleeding warning applies to you, you have a history of stomach problems, such as heartburn, you have high blood pressure, heart disease, liver cirrhosis, or kidney disease, you are taking a diuretic, you have asthma.Close
- OTC - ASK DOCTOR/PHARMACIST
Before use if you are taking a prescription drug for:
- OTC - 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,
allergic reaction occurs seek medical help right away,
pain gets worse or lasts more than 10 days,
redness or swelling is present,
new symptoms occur,
ringing in the ears or loss of hearing occurs.Close
- OTC - PREGNANCY 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.Close
- OTC - KEEP OUT OF REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control Center right away.Close
- DOSAGE AND ADMINISTRATION
Drink with a full glass of water with each dose
Adults and children 12 years and over Take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor Children under 12 years Consult a doctor
Store at 15°-30°C (59°-86°F). Do not use if imprinted seal under cap is missing or damaged.Close
- INACTIVE INGREDIENT
Anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide, triethyl citrate.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
aspirin tablet, delayed release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11534-155 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FERRIC OXIDE RED (UNII: 1K09F3G675) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) DIMETHICONE (UNII: 92RU3N3Y1O) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color YELLOW Score no score Shape ROUND Size 7mm Flavor Imprint Code heart Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11534-155-11 120 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 01/03/2010 Labeler - Sunrise Pharmaceutical Inc (168522378)