Country: United States
Language: English
Source: NLM (National Library of Medicine)
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)
RUGBY LABORATORIES
ORAL
OTC DRUG
Antacid relieves - acid indigestion - heartburn - sour stomach - upset stomach associated with these symptoms
OTC monograph final
CALCIUM CARBONATE 10 GR (648 MG) (ANTACID)- CALCIUM CARBONATE 10GR (648 MG) TABLET RUGBY LABORATORIES _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._ ---------- DRUG FACTS ACTIVE INGREDIENT (IN EACH TABLET) Calcium Carbonate 10 gr (648 mg) PURPOSE Antacid USES relieves acid indigestion heartburn sour stomach upset stomach associated with these symptoms WARNINGS ASK A DOCTOR BEFORE USE IF YOU HAVE kidney stones a calcium-restricted diet ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking a prescription drug. Antacids may interact with certain prescription drugs. STOP USE AND ASK A DOCTOR IF symptoms last more than 2 weeks. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. DIRECTIONS take one to four tablets daily do not take more than 4 tablets in 24 hours do not use the maximum dosage for more than two weeks OTHER INFORMATION each tablet contains: CALCIUM 260 MG store at room temperature INACTIVE INGREDIENTS acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid QUESTIONS OR COMMENTS? 1-800-645-2158 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING This is a bulk package. Dispense contents with a child-resistant closure in a tight, light- resistant container as defined in the USP. NDC 0536-1206-10 RUGBY CALCIUM CARBONATE 10 GR (648 MG) ANTACID 1000 TABLETS CALCIUM CARBONATE 10 GR (648 MG) (ANTACID) ® calcium carbonate 10gr (648 mg) tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:0536-1206 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 648 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ACACIA (UNII: 5C5403N26O) CROSCA Read the complete document