TUMS- calcium carbonate tablet GlaxoSmithKline Cons umer Heathcare LP 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 (per tablet) Calcium Carbonate USP 500 mg Purpose Antacid Uses relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 15 tablets in 24 hours if pregnant do not take more than 10 tablets in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor 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 a doctor do not take for symptoms that persist for more than 2 weeks unless advised by a doctor Other information each tablet contains: elemental calcium 200mg store below 30oC (86oF)
Inactive ingredients (assorted fruit) Adipic acid, corn starch, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc Inactive ingredient (peppermint) corn starch, flavor, mineral oil, sodium polyphosphate, sucrose, talc Questions? 1-800-897-7535 weekdays Safety sealed- Do not use if printed inner seal beneath cap is missing or broken. Gluten-Free www.tums.com GlaxoSmithKline Moon Twp, PA 15108 PRINCIPAL DISPLAY PANEL NDC 0135-0071-27 TUMS CALCIUM CARBONATE ANTACID REGULAR STRENGTH 500 Goes to Work in Seconds! Assorted Fruit 150 CHEWABLE TABLETS PAREVE 2014 GSK Front Label: 103784XA Back Label: 103783XA
Principal Dis play Panel NDC 0135-0070-27
TUMS CALCIUM CARBONATE ANTACID REGULAR STRENGTH 500 Goes to Work in Seconds! Peppermint 150 CHEWABLE TABLETS PAREVE 2014 GSK Front Label: 103781XA Back Label: 103780XA
TUMS
calcium carbonate tablet Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:0 135-0 0 71 Route of Administration ORAL DEA Sche dule Active Ing redient/active Moiety CALCIUM CARBO NATE (UNII: H0 G9 379 FGK) (CALCIUM CATION - UNII:2M8 3C4R6 ZB, CARBONATE ION - UNII:7UJQ5OPE7D) Basis of CALCIUM CARBONATE 50 0 mg Inactive Ing redients ADIPIC ACID (UNII: 76 A0 JE0 FKJ) STARCH, CO RN (UNII: O8 232NY3SJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 4 0 (UNII: WZB9 127XOA) FD&C YELLO W NO. 5 (UNII: I753WB2F1M) FD&C YELLO W NO. 6 (UNII: H77VEI9 3A8 ) MINERAL O IL (UNII: T5L8 T28 FGP) SO DIUM PO LYMETAPHO SPHATE (UNII: P1BM4ZH9 5L) SUCRO SE (UNII: C151H8 M554) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color PINK (o range, yello w, green) S core no sco re Shape ROUND Siz e 16 mm Flavor CHERRY (asso rted fruit, o range, lemo n, lime) Imp rint Cod e TUMS Contains Packag ing # Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date 1 NDC:0 135-0 0 71-27 150 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 3/10 /20 10 2 NDC:0 135-0 0 71-48 12 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct 0 3/10 /20 10 Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph final part331 0 3/10 /20 10 TUMS
calcium carbonate tablet Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:0 135-0 0 70 Route of Administration ORAL DEA Sche dule Active Ing redient/active Moiety CALCIUM CARBO NATE (UNII: H0 G9 379 FGK) (CALCIUM CATION - UNII:2M8 3C4R6 ZB, CARBONATE ION - UNII:7UJQ5OPE7D) Basis of CALCIUM CARBONATE 50 0 mg Inactive Ing redients STARCH, CO RN (UNII: O8 232NY3SJ) MINERAL O IL (UNII: T5L8 T28 FGP) SO DIUM PO LYMETAPHO SPHATE (UNII: P1BM4ZH9 5L) SUCRO SE (UNII: C151H8 M554) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE S core no sco re Shape ROUND Siz e 16 mm Flavor PEPPERMINT Imp rint Cod e TUMS Contains Packag ing # Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date 1 NDC:0 135-0 0 70-0 3 3 in 1 CELLO PACK 0 3/10 /20 10 1 12 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct 2 NDC:0 135-0 0 70-27 150 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 3/10 /20 10 3 NDC:0 135-0 0 70-48 12 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct 0 3/10 /20 10 Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph final part331 0 3/10 /20 10 Labeler - GlaxoSmithKline Cons umer Heathcare LP (828924212) Revised: 10/2014 GlaxoSmithKline Consumer Heathcare LP