TUMS
Drug Facts
Approved
Approval ID
f4786707-a0f7-4ba8-9656-06278d1b4b6c
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 22, 2025
Manufacturers
FDA
Haleon US Holdings LLC
DUNS: 079944263
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
calcium carbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0135-0181
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
calcium carbonate
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2025
FDA Product Classification
INGREDIENTS (10)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
ADIPIC ACIDInactive
Code: 76A0JE0FKJ
Classification: IACT
SODIUM POLYMETAPHOSPHATEInactive
Code: P1BM4ZH95L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 1000 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
calcium carbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0135-0118
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
calcium carbonate
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2025
FDA Product Classification
INGREDIENTS (12)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
ADIPIC ACIDInactive
Code: 76A0JE0FKJ
Classification: IACT
SODIUM POLYMETAPHOSPHATEInactive
Code: P1BM4ZH95L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 1000 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
calcium carbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0135-0180
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
calcium carbonate
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2025
FDA Product Classification
INGREDIENTS (10)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 1000 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
SODIUM POLYMETAPHOSPHATEInactive
Code: P1BM4ZH95L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
calcium carbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0135-0228
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
calcium carbonate
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2025
FDA Product Classification
INGREDIENTS (6)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 1000 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
SODIUM POLYMETAPHOSPHATEInactive
Code: P1BM4ZH95L
Classification: IACT
calcium carbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0135-0540
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
calcium carbonate
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2025
FDA Product Classification
INGREDIENTS (10)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SODIUM POLYMETAPHOSPHATEInactive
Code: P1BM4ZH95L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 1000 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 9/25/2024
Principal Display Panel – Peppermint (Tricolor)
NDC 0135-0540-01
TUMS®
ANTACID
CALICUM CARBONATE
PEPPERMINT
ULTRASTRENGTH1000
86CHEWABLETABLETS
20% MORE FREE
PAREVE
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 2/10/2015
Uses
relieves
- heartburn
- acid indigestion
- sour stomach
- upset stomach associated with these symptoms
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 9/25/2024
Active ingredient (per tablet)
Calcium Carbonate 1000 mg
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 2/10/2015
Purpose
Antacid
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 2/10/2015
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
WARNINGS SECTION
LOINC: 34071-1Updated: 9/25/2024
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.
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 9/25/2024
Directions
***adults and children 12 years of age and over:**chew 2-3 tablets as symptoms occur, or as directed by a doctor. Chew or crush tablets completely before swallowing.
- do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 9/25/2024
Other information– (Tropical Fruit and Assorted Fruit)
***each tablet contains:**elemental calcium 410 mg, magnesium 5 mg, sodium 2mg
- store below 30 oC (86 oF)
- contains FD&C Yellow No. 5 (tartrazine) as a color additive
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 9/25/2024
Questions?
1-800-897-7535
Safety sealed- Do not use if printed inner seal beneath cap is missing or broken.
Gluten-Free