TUMS EX- calcium carbonate tablet

TUMS by

Drug Labeling and Warnings

TUMS by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, GlaxoSmithKline Consumer Healthcare LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (per tablet)

Calcium Carbonate USP 750 mg

Purpose

Antacid

Uses

relieves

• heartburn
• acid indigestion
• sour stomach
• upset stomach associated with these symptoms

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.

When using this product

• do not take more than 10 tablets in 24 hours
• if pregnant do not take more than 6 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.

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.

When using this product

• do not take more than 9 tablets in 24 hours
• if pregnant do not take more than 6 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 (Assorted Fruit, Assorted Berries, Assorted Tropical Fruit, Wintergreen, Cherry)

• each tablet contains: elemental calcium 300mg, sodium 2mg
• store below 30°C (86°F)

Other information (Orange Cream)

• each tablet contains: elemental calcium 300mg
• store below 30°C (86°F)

Phenylketonurics: Contains phenylalanine, less than 1mg per tablet.

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 ingredients (Assorted Berries)

adipic acid, corn starch, FD&C blue #1 lake, FD&C red #40 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc

Inactive ingredients (Sugar Free Orange Cream)

acacia, adipic acid, aspartame, calcium stearate, FD&C yellow #6 lake, flavors, sorbitol

Inactive ingredient (Assorted Tropical Fruit)

corn starch, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc

Inactive ingredients (Wintergreen)

corn starch, FD&C blue #1 lake, FD&C yellow #5 (tartrazine) lake, flavor, mineral oil, sodium polyphosphate, sucrose, talc

Inactive ingredients (Cherry)

adipic acid, corn starch, FD&C red #40 lake, flavor, mineral oil, sodium polyphosphate, sucrose, talc

Questions?

1-800-897-7535weekdays

Safety sealed – Do not use if printed inner seal beneath cap is missing or broken.

Gluten-Free

www.tums.com

GSK Consumer Healthcare

Warren, NJ 07059

Principal Display Panel

NDC: 0135-0074-25

TUMS®

CALCIUM CARBONATE

ANTACID

Assorted Fruit

EXTRA STRENGTH 750

96 CHEWABLE TABLETS

GOES TO WORK IN SECONDS!

PAREVE

©2014 GSK

Front Label: 103703XA

Back Label: 103589XA

Principal Display Panel

NDC: 0135-0178-03

TUMS®

CALCIUM CARBONATE

ANTACID

Assorted Berries

EXTRA STRENGTH 750

96 CHEWABLE TABLETS

GOES TO WORK IN SECONDS!

PAREVE

©2014 GSK

Front Label: 103663XA

Back Label: 103590XA

Principal Display Panel

NDC: 0135-0154-05

TUMS®

CALCIUM CARBONATE

ANTACID

Sugar-Free Orange

EXTRA STRENGTH 750

80 CHEWABLE TABLETS

GOES TO WORK IN SECONDS!

PAREVE

©2014 GSK

Front Label: 103720XA

Back Label: 103719XA

Principal Display Panel

NDC: 0135-0140-03

TUMS®

CALCIUM CARBONATE

ANTACID

Tropical Fruit

EXTRA STRENGTH 750

96 CHEWABLE TABLETS

GOES TO WORK IN SECONDS!

PAREVE

©2014 GSK

Front Label: 103704XA

Back Label: 103705XA

Principal Display Panel

NDC: 0135-0076-25

TUMS®

CALCIUM CARBONATE

ANTACID

Wintergreen

EXTRA STRENGTH 750

96 CHEWABLE TABLETS

GOES TO WORK IN SECONDS!

PAREVE

©2014 GSK

Front Label: 103707XA

Back Label: 103708XA

Principal Display Panel

NDC: 0135-0521-02

TUMS®

CALCIUM CARBONATE

ANTACID

Cherry

EXTRA STRENGTH 750

96 CHEWABLE TABLETS

GOES TO WORK IN SECONDS!

PAREVE

©2014 GSK

Front Label: 103710XA

Back Label: 103711XA

INGREDIENTS AND APPEARANCE

TUMS  EX
calcium carbonate tablet

Product 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 tablet

Product 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 tablet

Product 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 tablet

Product 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 tablet

Product 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 tablet

Product 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)