国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)
O4 Global Trading Usa, Llc
ORAL
OTC DRUG
Antacid • relieves • acid indigestion. • heartburn.
OTC monograph final
ONLY FOR ANTACID- CALCIUM CARBONATE TABLET, CHEWABLE O4 GLOBAL TRADING USA, LLC _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._ ---------- _ONLY FOR_ - ANTACID _DRUG FATCS_ _ACTIVE INGREDIENT (IN EACH TABLET)_ Calcium Carbonate 500mg _PURPOSE_ Antacid _USES:_ • relieves • acid indigestion. • heartburn. _WARNINGS:_ ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE presently taking a prescription drug. Antacids may interact with certain prescription drugs. DO NOT USE DO NOT TAKE more than 15 tablets in a 24 - hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor. May cause constipation. May have laxative effect. IF PREGNANT OR BREAST - FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. _DIRECTIONS_ • ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER: chew 2 - 4 tablets as symptoms occur, or as directed by doctor. _OTHER INFORMATION_ each tablet contains: elemental calcium 200mg store at room temperature between 20-25°C (68-77°F). _INACTIVE INGREDIENTS_ adipic acid, corn starch, crospovidone, D&C red #27 lake, D&C red #30 lake, D&C yellow #10 lake, dextrose, FD&C yellow #6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc. _QUESTIONS OR COMMENTS ?_ _1-833-665-9444._ _NDC: 73006-118-41_ DISTRIBUTED BY: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010. www.onlyfor.com PACKAGED BY: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816 _TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS_ _TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING_ TEAR ALONG PERFORATION PUSH PRODUCT THROUGH FOIL PACKAGING ONLY FOR ANTACID calcium carbonate tablet, chewable PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:730 0 6 -118 ROUTE OF ADMINISTRATION ORAL O4 Global Trading Usa, Llc ACTIVE INGREDIEN 阅读完整的文件