TUMS SMOOTHIES- calcium carbonate tablet, chewable

TUMS by

Drug Labeling and Warnings

TUMS by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. 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

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.

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 300mg
• store below 25oC (77oF). Keep the container tightly closed.

Inactive ingredients (Assorted Fruit)

adipic acid, corn starch, dextrose, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Contains: soy

Inactive ingredients (Berry Fusion)

adipic acid, corn starch, dextrose, FD&C blue #1 lake, FD&C red #40 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Contains: soy

Inactive ingredient (Assorted Tropical Fruit)

adipic acid, corn starch, dextrose, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Contains: soy

Inactive ingredients (Peppermint)

corn starch, dextrose, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Questions?

1-800-897-7535 weekdays

Principal Display Panel

NDC: 0135-0246-02

TUMS®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Assorted Fruit

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60 CHEWABLE TABLETS

PAREVE

©2014 GSK

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

GlaxoSmithKline

Moon Twp, PA 15108

Gluten-Free

www.tums.com

Front Panel 103644XA

Back Panel 103553XA

Principal Display Panel

NDC: 0135-0456-03

TUMS®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Berry Fusion

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60 CHEWABLE TABLETS

PAREVE

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

GSK CH

Warren, NJ 07059

Gluten-Free

©2014 GSK

Front Panel 103680XA

Back Panel 103725XA

Principal Display Panel

NDC: 0135-0245-02

TUMS®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Tropical Fruit

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60 CHEWABLE TABLETS

PAREVE

©2014 GSK

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

GlaxoSmithKline

Moon Twp, PA 15108

Gluten-Free

www.tums.com

Front Panel 103818XA

Back Panel 103816XA

Principal Display Panel

NDC: 0135-0243-02

TUMS®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Peppermint

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60 CHEWABLE TABLETS

PAREVE

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

Trademarks are owned by or licensed to the GSK group of companies.

GSK Consumer Healthcare

Warren, NJ 07059

Gluten-Free

©2015 GSK or its licensor.

Front Panel 103728XB

Back Panel 103727XB

INGREDIENTS AND APPEARANCE

TUMS  SMOOTHIES
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0246
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)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
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)
GUAR GUM (UNII: E89I1637KE)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	PINK (orange, dark pink, yellow)	Score	no score
Shape	ROUND	Size	19mm
Flavor	CHERRY (Assorted flavor, orange, strawberry, lemon)	Imprint Code	TUMS;SD
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0246-01	12 in 1 CELLO PACK; Type 0: Not a Combination Product	03/24/2010
2	NDC: 0135-0246-02	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2010
3	NDC: 0135-0246-05	140 in 1 BOTTLE; Type 0: Not a Combination Product	08/10/2014
4	NDC: 0135-0246-07	250 in 1 BOTTLE; Type 0: Not a Combination Product	01/26/2016
5	NDC: 0135-0246-04	72 in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/24/2010

TUMS  SMOOTHIES
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0456
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)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GUAR GUM (UNII: E89I1637KE)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	PINK (mauve, peach, dark pink)	Score	no score
Shape	ROUND	Size	19mm
Flavor	CHERRY (Berry Fusion, citrus berry, orange passion, strawberry)	Imprint Code	TUMS;SD
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0456-01	12 in 1 CELLO PACK; Type 0: Not a Combination Product	03/24/2010
2	NDC: 0135-0456-03	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2010
3	NDC: 0135-0456-04	72 in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2010
4	NDC: 0135-0456-05	140 in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/24/2010

TUMS  SMOOTHIES
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0245
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)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GUAR GUM (UNII: E89I1637KE)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	ORANGE (peach, mauve)	Score	no score
Shape	ROUND	Size	19mm
Flavor	ORANGE (Assorted Tropical Fruit, orange passion, citrus berry, mixed fruit)	Imprint Code	TUMS;SD
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0245-02	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/24/2010

TUMS  SMOOTHIES
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0243
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)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
GUAR GUM (UNII: E89I1637KE)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	19mm
Flavor	PEPPERMINT	Imprint Code	TUMS;SD
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0243-02	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/24/2010

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)