Active Ingredient (Per Tablet)
Calcium Carbonate USP 750 mg
Tums Tablet, Chewable
FDA Label NDC 0135-0221
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Tums (NDC 0135-0221). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (per tablet), purpose, uses, ask a doctor or pharmacist before use if you are, when using this product, directions, other information, inactive ingredients (assorted fruit), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Uses
relieves
- heartburn
- acid indigestion
- sour stomach
- upset stomach associated with these symptoms
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
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 (Image 01)
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 (58afb9fd C44a 41a8 Aa2f F535e6258539 02)
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 (58afb9fd C44a 41a8 Aa2f F535e6258539 03)
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 (58afb9fd C44a 41a8 Aa2f F535e6258539 04)
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