TUMS EX- calcium carbonate tablet 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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Drug Facts

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

Tums Extra Strength Assorted Fruit 96 count front label

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

Tums Extra Strength Assorted Berries 96 count front label

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

Tums Extra Strength Sugar Free Orange 80 count front label

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

Tums Extra Strength Tropical Fruit 96 count front label

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

Tums Extra Strength Wintergreen 96 count front label

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

Tums Extra Strength Cherry 96 count front label
TUMS  EX
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0074
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINK, ORANGE, YELLOW, GREENScoreno score
ShapeROUNDSize16mm
FlavorCHERRY (Assorted fruit flavor, orange, lemon, lime) Imprint Code TUMS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0074-01116 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
2NDC:0135-0074-2248 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
3NDC:0135-0074-243 in 1 CELLO PACK01/18/2010
38 in 1 PACKAGE; Type 0: Not a Combination Product
4NDC:0135-0074-2596 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
5NDC:0135-0074-468 in 1 PACKAGE; Type 0: Not a Combination Product01/18/2010
6NDC:0135-0074-0670 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
7NDC:0135-0074-07330 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
8NDC:0135-0074-473 in 1 PACKAGE10/15/2017
896 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/18/2010
TUMS  EX
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0178
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINK, RED (mauve) , BLUE (bluish) Scoreno score
ShapeROUNDSize16mm
FlavorSTRAWBERRY (Assorted Berry, raspberry, mixed berry) Imprint Code TUMS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0178-01116 in 1 BOTTLE; Type 0: Not a Combination Product01/18/201004/30/2019
2NDC:0135-0178-09200 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
3NDC:0135-0178-088 in 1 PACKAGE; Type 0: Not a Combination Product01/18/2010
4NDC:0135-0178-0570 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
5NDC:0135-0178-0248 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
6NDC:0135-0178-0396 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/18/2010
TUMS  EX
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0154
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGE (orange cream) Scoreno score
ShapeROUNDSize16mm
FlavorORANGE (ORANGE CREAM) Imprint Code TUMS;FREE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0154-0296 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
2NDC:0135-0154-0580 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/18/2010
TUMS  EX
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0140
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorRED (red-orange) , ORANGE, WHITE (cream) , YELLOW (light yellow) Scoreno score
ShapeROUNDSize16mm
FlavorTROPICAL FRUIT PUNCH (Assorted tropical fruit flavor, tropical punch, mandarin orange, orange-pineapple, strawberry-banana) Imprint Code TUMS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0140-05116 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
2NDC:0135-0140-0396 in 1 BOTTLE; Type 0: Not a Combination Product01/18/201009/30/2018
3NDC:0135-0140-018 in 1 PACKAGE; Type 0: Not a Combination Product01/18/2010
4NDC:0135-0140-10330 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
5NDC:0135-0140-0248 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/18/2010
TUMS  EX
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0076
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScoreno score
ShapeROUNDSize16mm
FlavorWINTERGREENImprint Code TUMS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0076-01116 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
2NDC:0135-0076-2596 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
3NDC:0135-0076-2670 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/18/2010
TUMS  EX
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0521
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScoreno score
ShapeROUNDSize16mm
FlavorCHERRYImprint Code TUMS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0521-018 in 1 PACKAGE; Type 0: Not a Combination Product03/23/2011
2NDC:0135-0521-0296 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33103/23/2011
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
GlaxoSmithKline Consumer Healthcare LP832116797LABEL(0135-0074, 0135-0178)

Revised: 4/2021
Document Id: f8e38186-22b2-454e-a24d-03f8d983e495
Set id: 593a0494-d669-4bcf-8412-b92645b2d76c
Version: 13
Effective Time: 20210415
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC