Citric Acid

FDA Drug Profile — Earthmed Soothe Chewable Watermelon, Earthmed Soothe Chewable Strawberry, Soothe Chewable, Earthmed Soothe Chewable Orange, Earthmed Soothe Chewable Cherry

Drug Details

Generic Name
Citric Acid
Brand Names
Earthmed Soothe Chewable Watermelon, Earthmed Soothe Chewable Strawberry, Soothe Chewable, Earthmed Soothe Chewable Orange, Earthmed Soothe Chewable Cherry
Application Number
M001
Sponsor
Earthmed LLC
NDC Codes
8
Dosage Forms
CHEWABLE GEL
Routes
ORAL
Active Ingredients
CITRIC ACID MONOHYDRATE

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 ealy sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a sever 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 (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