Label: TUMS EX- calcium carbonate tablet
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NDC Code(s):
0135-0074-01,
0135-0074-06,
0135-0074-07,
0135-0074-22, view more0135-0074-24, 0135-0074-25, 0135-0074-46, 0135-0074-47, 0135-0076-01, 0135-0076-25, 0135-0076-26, 0135-0140-01, 0135-0140-02, 0135-0140-03, 0135-0140-05, 0135-0140-10, 0135-0154-02, 0135-0154-05, 0135-0178-01, 0135-0178-02, 0135-0178-03, 0135-0178-05, 0135-0178-08, 0135-0178-09, 0135-0521-01, 0135-0521-02
- 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 April 15, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (per tablet)
- Purpose
- Uses
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Warnings (Assorted Fruit, Assorted Berries, Assorted Tropical Fruit, Wintergreen, Cherry)
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug. Antacids may interact with certain prescription drugs.
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Warnings (Sugar Free Orange Cream)
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 (Assorted Fruit, Assorted Berries, Assorted Tropical Fruit, Wintergreen, Cherry)
- Other information (Orange Cream)
- Inactive ingredients (Assorted Fruit)
- Inactive ingredients (Assorted Berries)
- Inactive ingredients (Sugar Free Orange Cream)
- Inactive ingredient (Assorted Tropical Fruit)
- Inactive ingredients (Wintergreen)
- Inactive ingredients (Cherry)
- Questions?
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INGREDIENTS AND APPEARANCE
TUMS EX
calcium carbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0074 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 750 mg Inactive Ingredients Ingredient Name Strength ADIPIC ACID (UNII: 76A0JE0FKJ) STARCH, CORN (UNII: O8232NY3SJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MINERAL OIL (UNII: T5L8T28FGP) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color PINK, ORANGE, YELLOW, GREEN Score no score Shape ROUND Size 16mm Flavor CHERRY (Assorted fruit flavor, orange, lemon, lime) Imprint Code TUMS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0074-01 116 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 2 NDC:0135-0074-22 48 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 3 NDC:0135-0074-24 3 in 1 CELLO PACK 01/18/2010 3 8 in 1 PACKAGE; Type 0: Not a Combination Product 4 NDC:0135-0074-25 96 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 5 NDC:0135-0074-46 8 in 1 PACKAGE; Type 0: Not a Combination Product 01/18/2010 6 NDC:0135-0074-06 70 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 7 NDC:0135-0074-07 330 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 8 NDC:0135-0074-47 3 in 1 PACKAGE 10/15/2017 8 96 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 01/18/2010 TUMS EX
calcium carbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0178 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 750 mg Inactive Ingredients Ingredient Name Strength ADIPIC ACID (UNII: 76A0JE0FKJ) STARCH, CORN (UNII: O8232NY3SJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C RED NO. 40 (UNII: WZB9127XOA) MINERAL OIL (UNII: T5L8T28FGP) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color PINK, RED (mauve) , BLUE (bluish) Score no score Shape ROUND Size 16mm Flavor STRAWBERRY (Assorted Berry, raspberry, mixed berry) Imprint Code TUMS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0178-01 116 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 04/30/2019 2 NDC:0135-0178-09 200 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 3 NDC:0135-0178-08 8 in 1 PACKAGE; Type 0: Not a Combination Product 01/18/2010 4 NDC:0135-0178-05 70 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 5 NDC:0135-0178-02 48 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 6 NDC:0135-0178-03 96 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 01/18/2010 TUMS EX
calcium carbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0154 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 750 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) ADIPIC ACID (UNII: 76A0JE0FKJ) ASPARTAME (UNII: Z0H242BBR1) CALCIUM STEARATE (UNII: 776XM7047L) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) ALUMINUM OXIDE (UNII: LMI26O6933) SORBITOL (UNII: 506T60A25R) Product Characteristics Color ORANGE (orange cream) Score no score Shape ROUND Size 16mm Flavor ORANGE (ORANGE CREAM) Imprint Code TUMS;FREE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0154-02 96 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 2 NDC:0135-0154-05 80 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 01/18/2010 TUMS EX
calcium carbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0140 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 750 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) FD&C RED NO. 40 (UNII: WZB9127XOA) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MINERAL OIL (UNII: T5L8T28FGP) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color RED (red-orange) , ORANGE, WHITE (cream) , YELLOW (light yellow) Score no score Shape ROUND Size 16mm Flavor TROPICAL FRUIT PUNCH (Assorted tropical fruit flavor, tropical punch, mandarin orange, orange-pineapple, strawberry-banana) Imprint Code TUMS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0140-05 116 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 2 NDC:0135-0140-03 96 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 09/30/2018 3 NDC:0135-0140-01 8 in 1 PACKAGE; Type 0: Not a Combination Product 01/18/2010 4 NDC:0135-0140-10 330 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 5 NDC:0135-0140-02 48 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 01/18/2010 TUMS EX
calcium carbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0076 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 750 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) MINERAL OIL (UNII: T5L8T28FGP) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color GREEN Score no score Shape ROUND Size 16mm Flavor WINTERGREEN Imprint Code TUMS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0076-01 116 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 2 NDC:0135-0076-25 96 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 3 NDC:0135-0076-26 70 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 01/18/2010 TUMS EX
calcium carbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0521 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 750 mg Inactive Ingredients Ingredient Name Strength ADIPIC ACID (UNII: 76A0JE0FKJ) STARCH, CORN (UNII: O8232NY3SJ) FD&C RED NO. 40 (UNII: WZB9127XOA) ALUMINUM OXIDE (UNII: LMI26O6933) MINERAL OIL (UNII: T5L8T28FGP) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color PINK Score no score Shape ROUND Size 16mm Flavor CHERRY Imprint Code TUMS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0521-01 8 in 1 PACKAGE; Type 0: Not a Combination Product 03/23/2011 2 NDC:0135-0521-02 96 in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 03/23/2011 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) Establishment Name Address ID/FEI Business Operations GlaxoSmithKline Consumer Healthcare LP 832116797 LABEL(0135-0074, 0135-0178)