Label: TUMS ULTRA- calcium carbonate tablet, chewable
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NDC Code(s):
0135-0118-01,
0135-0118-04,
0135-0118-14,
0135-0118-83, view more0135-0180-01, 0135-0180-02, 0135-0180-14, 0135-0181-01, 0135-0181-02, 0135-0181-03, 0135-0181-05, 0135-0181-06, 0135-0181-07, 0135-0181-14, 0135-0228-01, 0135-0228-04, 0135-0228-05, 0135-0228-06, 0135-0228-07, 0135-0540-01
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated December 1, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (per tablet)
- Purpose
- Uses
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Warnings
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug. Antacids may interact with certain prescription drugs.
- Directions
- Other information
- Inactive ingredients (Assorted Fruit)
- Inactive ingredients (Assorted Tropical Fruit)
- Inactive ingredients (Assorted Berry)
- Inactive ingredient (Peppermint)
- Inactive ingredients (Peppermint Tri-Color)
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INGREDIENTS AND APPEARANCE
TUMS ULTRA
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0118 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 1000 mg Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) MINERAL OIL (UNII: T5L8T28FGP) ADIPIC ACID (UNII: 76A0JE0FKJ) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color PINK (orange, yellow, green) Score no score Shape ROUND Size 19mm Flavor CHERRY (assorted fruit, orange, lemon, lime) Imprint Code TUMS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0118-01 86 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 2 NDC:0135-0118-04 265 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 3 NDC:0135-0118-14 160 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 4 NDC:0135-0118-83 72 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 02/12/2010 TUMS ULTRA
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0180 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 1000 mg Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) MINERAL OIL (UNII: T5L8T28FGP) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color ORANGE (red-orange, cream to off-white, light yellow) Score no score Shape ROUND Size 19mm Flavor TROPICAL FRUIT PUNCH (assorted tropical fruit, mandarin orange, orange-pineapple, strawberry-banana) Imprint Code TUMS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0180-01 86 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 2 NDC:0135-0180-02 72 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 3 NDC:0135-0180-14 160 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 02/12/2010 TUMS ULTRA
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0181 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 1000 mg Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) MINERAL OIL (UNII: T5L8T28FGP) ADIPIC ACID (UNII: 76A0JE0FKJ) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color PINK (mauve, bluish) Score no score Shape ROUND Size 19mm Flavor BERRY (assorted berry, strawberry, raspberry, mixed berry) Imprint Code TUMS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0181-01 3 in 1 CARTON 02/12/2010 1 12 in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:0135-0181-02 72 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 3 NDC:0135-0181-03 12 in 1 PACKAGE; Type 0: Not a Combination Product 02/12/2010 4 NDC:0135-0181-05 265 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 5 NDC:0135-0181-06 86 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 6 NDC:0135-0181-07 1 in 1 CARTON 02/12/2010 6 12 in 1 PACKAGE; Type 0: Not a Combination Product 7 NDC:0135-0181-14 160 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 02/12/2010 TUMS ULTRA
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0228 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 1000 mg Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) MINERAL OIL (UNII: T5L8T28FGP) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) Product Characteristics Color WHITE Score no score Shape ROUND Size 19mm Flavor PEPPERMINT Imprint Code TUMS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0228-01 12 in 1 PACKAGE; Type 0: Not a Combination Product 02/12/2010 2 NDC:0135-0228-04 10 in 1 PACKAGE; Type 0: Not a Combination Product 02/12/2010 3 NDC:0135-0228-05 160 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 4 NDC:0135-0228-06 72 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 5 NDC:0135-0228-07 86 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/2015 04/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 02/12/2010 TUMS ULTRA
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0540 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 1000 mg Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) MINERAL OIL (UNII: T5L8T28FGP) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) FD&C RED NO. 40 (UNII: WZB9127XOA) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color WHITE, RED, GREEN Score no score Shape ROUND Size 19mm Flavor PEPPERMINT Imprint Code TUMS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0540-01 86 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 02/12/2010 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)