Asprin and Caffeine

FDA Drug Profile — Anacin

Drug Details

Generic Name
Asprin and Caffeine
Brand Names
Anacin
Application Number
M013
Sponsor
Insight Pharmaceuticals LLC
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
ASPIRIN, CAFFEINE

Indications and Usage

Uses temporarily relieves minor aches and pains due to Headache toothache muscular aches a cold backache arthritis menstrual cramps

Warnings

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 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 thinner (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 Caffeine warning This product contains caffeine. Limit the use of caffeine-containing medications, foods or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor before use if the 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 Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes gout arthritis Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. 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 ringing in the ears or loss of hearing occurs redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These may be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at least 20 weeks or later in pregnancy unless definitely 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. Overdose warning In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.