Apirin, Citric Acid, Sodium Bicarbonate

FDA Drug Profile — Top Value Effervescent Pain Relief

Drug Details

Generic Name
Apirin, Citric Acid, Sodium Bicarbonate
Brand Names
Top Value Effervescent Pain Relief
Application Number
M013
Sponsor
Tower Laboratories Ltd
NDC Codes
1
Dosage Forms
TABLET, EFFERVESCENT
Routes
ORAL
Active Ingredients
ANHYDROUS CITRIC ACID, ASPIRIN, SODIUM BICARBONATE

Indications and Usage

Uses Uses for the temporary relief of ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains ■ upset stomach with headache from overindulgence in food or drink ■ pain alone (headaches or body aches and pains)

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 a nonsteroidal anti-inflammatory drug (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 non-prescription 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