TUMS SMOOTHIES- calcium carbonate tablet, chewable 
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

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

Tums Smoothies Assorted Fruit 60 count front label

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

Tums Smoothies Berry Fusion 60 count front label

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

Tums Smoothies Tropical Fruit 60 count front label

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

Tums Smoothies Peppermint 60 count front label
TUMS  SMOOTHIES
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0246
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)  
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
ColorPINK (orange, dark pink, yellow) Scoreno score
ShapeROUNDSize19mm
FlavorCHERRY (Assorted flavor, orange, strawberry, lemon) Imprint Code TUMS;SD
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0246-0112 in 1 CELLO PACK; Type 0: Not a Combination Product03/24/2010
2NDC:0135-0246-0260 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2010
3NDC:0135-0246-05140 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2014
4NDC:0135-0246-07250 in 1 BOTTLE; Type 0: Not a Combination Product01/26/2016
5NDC:0135-0246-0472 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33103/24/2010
TUMS  SMOOTHIES
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0456
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)  
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
ColorPINK (mauve, peach, dark pink) Scoreno score
ShapeROUNDSize19mm
FlavorCHERRY (Berry Fusion, citrus berry, orange passion, strawberry) Imprint Code TUMS;SD
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0456-0112 in 1 CELLO PACK; Type 0: Not a Combination Product03/24/2010
2NDC:0135-0456-0360 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2010
3NDC:0135-0456-0472 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2010
4NDC:0135-0456-05140 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33103/24/2010
TUMS  SMOOTHIES
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0245
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)  
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
ColorORANGE (peach, mauve) Scoreno score
ShapeROUNDSize19mm
FlavorORANGE (Assorted Tropical Fruit, orange passion, citrus berry, mixed fruit) Imprint Code TUMS;SD
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0245-0260 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33103/24/2010
TUMS  SMOOTHIES
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0243
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)  
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
ColorWHITEScoreno score
ShapeROUNDSize19mm
FlavorPEPPERMINTImprint Code TUMS;SD
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0243-0260 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33103/24/2010
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
Nutri Granulations017130076API MANUFACTURE(0135-0246, 0135-0456, 0135-0245, 0135-0243)

Revised: 1/2021
Document Id: 627e3c9e-5621-4d62-b1c8-46db7cae225f
Set id: c22944b8-8733-4689-be0c-f320467f79ea
Version: 15
Effective Time: 20210118
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC