Country: United States
Language: English
Source: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)
Citragen Pharmaceuticals Inc
ORAL
OTC DRUG
Electrolyte Replenisher - for the preparation of normal isotonic solution of sodium chloride - as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration - any alternative use as directed by a physician
OTC monograph final
SODIUM CHLORIDE NORMAL SALT- SODIUM CHLORIDE TABLET CITRAGEN PHARMACEUTICALS INC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- SODIUM CHLORIDE TABLETS, USP _DRUG FACTS_ _ACTIVE INGREDIENT (IN EACH TABLET)_ Sodium Chloride, USP 1.0 gram _PURPOSE_ Electrolyte Replenisher _USES_ for the preparation of normal isotonic solution of sodium chloride as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration any alternative use as directed by a physician _WARNINGS_ DO NOT USE without consulting a physician ASK A PHYSICIAN BEFORE USE IF YOU HAVE a sodium restricted diet due to multiple organ diseases STOP USE AND ASK A PHYSICIAN IF symptoms of heat cramps continue for more than 24 hours. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ to make isontonic solution of sodium chloride, dissolve one tablet in 120 ml (four ounces) of distilled water and use as directed by a physician. if used as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration take one tablet orally as directed by your physician. _OTHER INFORMATION:_ EACH TABLET CONTAINS: sodium 394 mg store at room temperature 15°-30°C (59°-86°F) product does not contain any inactive ingredients _QUESTIONS OR COMMENTS?_ Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: info@citragenpharma.com TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING MANUFACTURED BY: CitraGen Pharmaceuticals, Inc., Fremont, CA 94538. www.citragenpharma.com Rev. 02/19 R-00 _CITRAGEN PHARMACEUTICALS, INC._ NDC: 70369‐007‐02 SODIUM CHLORIDE TABLETS, USP 1 GRAM NORMAL SALT TABLETS FOR SOLUTION OR ORAL USE 500 Tablets THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDRE Read the complete document