Aspirin, Anhydrous Citric Acid, Sodium Bicarbonate

FDA Drug Profile — CVS Health Extra Strength Antacid and Pain Reliever, Quality Choice Extra Strength Effervescent Antacid and Pain Relief

Drug Details

Generic Name
Aspirin, Anhydrous Citric Acid, Sodium Bicarbonate
Brand Names
CVS Health Extra Strength Antacid and Pain Reliever, Quality Choice Extra Strength Effervescent Antacid and Pain Relief
Application Number
M013
Sponsor
CVS Pharmacy
NDC Codes
2
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 ■ headache, body aches and pain alone

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 thinning (anti-coagulant) 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