Tums Ultra (Calcium Carbonate) Tablet, Chewable [Glaxosmithkline Consumer Healthcare Holdings (Us) Llc] -

TUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC	0135-0118-01, 0135-0118-04, 0135-0118-14, 0135-0118-83, 0135-0180-01, 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
Set ID	f4786707-a0f7-4ba8-9656-06278d1b4b6c
Category	HUMAN OTC DRUG LABEL
Packager	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number	PART331

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Active ingredient (per tablet)

Calcium Carbonate USP 1000 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 7 tablets in 24 hours

•

if pregnant do not take more than 5 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 2-3 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 400mg, sodium 2mg

•

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 ingredients (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 (Assorted Berry)

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

corn starch, flavor, mineral oil, sodium polyphosphate, sucrose, talc
Inactive ingredients (Peppermint Tri-Color)

corn starch, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) 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.

www.tums.com

GlaxoSmithKline

Moon Twp, PA 15108

Gluten-Free
Principal Display Panel

NDC 0135-0118-83

TUMS®

CALCIUM CARBONATE

ANTACID

ASSORTED FRUIT

ULTRA STRENGTH 1000

72 CHEWABLE TABLETS

GOES TO WORK IN SECONDS!

©2014 GSK

PAREVE

103662XA (Front Label)

103593XA (Back Label)
Principal Display Panel

NDC 0135-0180-02

TUMS®

CALCIUM CARBONATE

ANTACID

TROPICAL FRUIT

ULTRA STRENGTH 1000

72 CHEWABLE TABLETS

GOES TO WORK IN SECONDS!

©2014 GSK

PAREVE

103634XA (Front Label)

103591XA (Back Label)
Principal Display Panel

NDC 0135-0181-02

TUMS®

CALCIUM CARBONATE

ANTACID

ASSORTED BERRIES

ULTRA STRENGTH 1000

72 CHEWABLE TABLETS

GOES TO WORK IN SECONDS!

©2014 GSK

PAREVE

103665XA (Front Label)

103588XA (Back Label)
Principal Display Panel

NDC 0135-0228-06

TUMS®

CALCIUM CARBONATE

ANTACID

PEPPERMINT

ULTRA STRENGTH 1000

72 CHEWABLE TABLETS

GOES TO WORK IN SECONDS!

©2014 GSK

103664XA (Front Label)

103592XA (Back Label)
Principal Display Panel

NDC 0135-0540-01

TUMS®

ANTACID

CALICUM CARBONATE

PEPPERMINT

ULTRA STRENGTH 1000

86 CHEWABLE TABLETS

20% MORE FREE

PAREVE

©2014 GSK

104475XA (Front Label)

104476XA (Back Label)

INGREDIENTS AND APPEARANCE

TUMS ULTRA
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0118
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	1000 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	02/12/2010

TUMS ULTRA
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0180
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	1000 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	02/12/2010

TUMS ULTRA
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0181
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	1000 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	02/12/2010

TUMS ULTRA
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0228
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	1000 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	02/12/2010

TUMS ULTRA
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0540
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	1000 mg

Ingredient Name	Strength
Inactive Ingredients
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)