Country: United States
Language: English
Source: NLM (National Library of Medicine)
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)
West-Ward Pharmaceuticals Corp.
CALCIUM CARBONATE
CALCIUM CARBONATE 1250 mg
OTC DRUG
OTC monograph final
CALCIUM CARBONATE- CALCIUM CARBONATE TABLET WEST-WARD PHARMACEUTICALS CORP. _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._ ---------- SUPPLEMENT FACTS CALCIUM CARBONATE TABLETS (NOT USP) CALCIUM SUPPLEMENT SUPPLEMENT FACTS SERVING SIZE: 1 TABLET AMOUNT PER SERVING % DAILY VALUE Calcium 500 mg 50 % ACTIVE INGREDIENT Each tablet contains 1250 mg calcium carbonate (equivalent to 500 mg elemental calcium). PURPOS E Antacid KEEP OUT OF REACH OF CHILDREN Keep bottle tightly closed. Store in a cool, dry place, OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center immediately. US ES For the prevention of calcium deficiency in adults. WARNINGS Do not use more than directed. As with any supplement, if you are pregnant or nursing a baby, contact your healthcare professional before use. DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING. DIRECTIONS Take one tablet two to three times daily with meals, or as directed by a physician. STORAGE AND HANDLING Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] INACTIVE INGREDIENTS Magnesium stearate and microcrystalline cellulose. QUESTIONS OR COMMENTS Call 1-800-962-8364. You may also report serious side effects to this phone number. Distr by: WEST-WARD PHARMACEUTICALS CORP. Eatontown, NJ 07724 REVISED MARCH 2016 PACKAGE/LABEL PRINCIPAL DISPLAY PANEL PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CALCIUM CARBONATE calcium carbonate tablet PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:0 0 54-4120 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH CALCIUM CARBO NATE (UNII: H0 G9 379 FGK) (CALCIUM CATION - UNII:2M8 3C4R6 ZB) CALCIUM CARBONATE 1250 mg INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 ) CELLULO SE, MICRO CRYSTALLINE (UNII: Read the complete document