Label: ASPIRIN - aspirin tablet
- NDC Code(s): 0536-3086-10, 0536-3086-41
- Packager: Rugby Laboratories 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 December 6, 2012
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- Active Ingredient
(in each tablet)
Aspirin 81 mgClose
- Temporarily relieves minor aches and pains
- For other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.
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 signs of Reye’s syndrome, a rare but serious illness.
Allergy Alert: Aspirin may cause a severe allergic reaction which may include
- facial swelling
- asthma (wheezing)
Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding.
The chances 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 non-prescription NSAIDs (ibuprofen, naproxen, or others)
- take more or for longer time than directed
- have 3 or more alcoholic drinks every day while using this product
Do not use if you have ever had an allergic reaction to any other pain reliever / fever reducer
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have 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
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout or arthritis
- under a doctor’s care for any serious condition
- taking any other drug
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
- 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 symptoms appear
- 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 three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complication 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 & older: take 4 or 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours
- children under 12 years: ask a doctor
- Other Information
- store at room temperature 15°-30°C (59°-86°F)
- Inactive Ingredients
croscarmellose sodium, D&C Yellow # 10 (AL-lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol/propylene glycol, PVP, silicon dioxide, sodium lauryl sulfate, corn starch, stearic acid, talc, titanium dioxideClose
- Questions or Comments
Call 1-800-645-2158, 9am–5pm ET, Monday - FridayClose
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
Aspirin 81 mg Tablets (NSAID)
Aspirin 81 mg Tablets (NSAID)
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3086 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSES (UNII: 3NXW29V3WO) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW Score no score Shape ROUND Size 8mm Flavor Imprint Code AP;121 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-3086-41 120 in 1 BOTTLE 2 NDC:0536-3086-10 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 04/28/2008 Labeler - Rugby Laboratories Inc. (191427277) Registrant - Advance Pharmaceutical Inc. (078301063) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 MANUFACTURE(0536-3086)