Label: ASPIRIN- aspirin tablet
- NDC Code(s): 68788-9671-1
- Packager: Preferred Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0603-0026
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENTS (IN EACH TABLET)
Aspirin 81mg (NSAID*)
*nonsteroidal anti-inflammatory drugClose
for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed 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 very serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- facial swelling
- asthma (wheezing)
if an allergic reaction occurs, stop use and seek medical help right away.
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
Ask a 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 have asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
Taking a prescription drug for:
- anticoagulation (thinning of the blood)
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
- new symptoms occur
- redness or swelling is present
- Ringing in the ears or loss of hearing occurs
- Pain gets worse or lasts for more than 10 days
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 specifically 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.
- drink 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
- OTHER INFORMATION
- store at room temperature
- do not use if imprinted safety seal under cap is broken or missing
You may report side effects to: 1-888-952-0050.Close
- INACTIVE INGREDIENTS
Anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow 10, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium laurel sulfate, talc, titanium dioxide, triethyl citrateClose
- PRINCIPAL DISPLAY PANEL
Delayed-Release Enteric Coated
Bottle of 120 - 68788-9671-1
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9671(NDC:0603-0026) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM HYDROXIDE (UNII: 55X04QC32I) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) DIMETHICONE (UNII: 92RU3N3Y1O) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-9671-1 120 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 06/06/2013 Labeler - Preferred Pharmaceuticals, Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals, Inc. 791119022 REPACK(68788-9671)