anhydrous citric acid

FDA Drug Profile — Citric Buffered Normal Saline

anhydrous citric acid is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Citric Buffered Normal Saline. Available dosage form: injection, solution.

Drug Details

Generic Name
anhydrous citric acid
Brand Names
Citric Buffered Normal Saline
Application Number
NDA211673
Sponsor
Meitheal Pharmaceuticals Inc.
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
ANHYDROUS CITRIC ACID

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