国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB), MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)
Chattem, Inc.
ORAL
OTC DRUG
Antacid Antacid relieves ■ heartburn ■ sour stomach ■ acid indigestion
OTC monograph final
ROLAIDS HEARTBURN SOOTHERS- CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE LOZENGE CHATTEM, 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._ ---------- ROLAIDS HEARTBURN SOOTHERS WINTERMINT _ROLAIDS HEARTBURN SOOTHERS - WINTERMINT (LOZENGES) _ _DRUG FACTS_ _ACTIVE INGREDIENTS (IN EACH LOZENGE)_ Calcium carbonate USP 440 mg Magnesium hydroxide USP 90 mg _PURPOSE_ Antacid Antacid _USES_ relieves ■ heartburn ■ sour stomach ■ acid indigestion _WARNINGS_ ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU are now taking a prescription drug. Antacids may interact with certain prescription drugs. WHEN USING THIS PRODUCT ■ do not use more than 15 lozenges in a 24-hour period ■ do not use the maximum dosage for more than 2 weeks KEEP OUT OF REACH OF CHILDREN. _DIRECTIONS_ ■ use 2-3 lozenges as symptoms occur, or as directed by a doctor _OTHER INFORMATION_ ■ EACH LOZENGE CONTAINS: calcium 175 mg, magnesium 40 mg _INACTIVE INGREDIENTS_ sucrose, corn syrup, glycerin, water, flavor, hydrogenated coconut oil, propylene glycol, menthol, blue 1 PRINCIPAL DISPLAY PANEL ROLAIDS Antacid Heartburn Soothers Wintermint (Lozenges) 18 Lozenges PRINCIPAL DISPLAY PANEL ROLAIDS Antacid Heartburn Soothers Wintermint (Lozenges) 36 Lozenges ROLAIDS HEARTBURN SOOTHERS calcium carbonate and magnesium hydroxide lozenge PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:4116 7-10 9 2 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 440 mg MAGNESIUM HYDRO XIDE (UNII: NBZ3QY0 0 4S) (MAGNESIUM CATION - UNII:T6 V3LHY8 38 ) MAGNESIUM HYDROXIDE 9 0 mg INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH FD&C BLUE NO . 1 (UNII: H3R47K3TBD) SUCRO SE (UNII: C151H8 M554) CO RN SYRUP (UNII: 9 G5L16 BK6 N) GLYCERIN (UNII: PDC6 阅读完整的文件