Citric Acid
Citric Acid is listed in the FDA National Drug Code directory with 8 NDC codes, marketed under brand names including Earthmed Soothe Chewable Orange, Earthmed Soothe Chewable Strawberry, Soothe Chewable. Available dosage form: chewable gel.
Drug Details
- Generic Name
- Citric Acid
- Brand Names
- Earthmed Soothe Chewable Orange, Earthmed Soothe Chewable Strawberry, Soothe Chewable, Earthmed Soothe Chewable Cherry, Earthmed Soothe Chewable Watermelon
- 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 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 (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