Active Ingredient (Per Tablet)
Calcium Carbonate USP 750 mg
Tums Tablet
FDA Label NDC 0135-0521
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 0135-0521). 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 (assorted fruit, assorted berries, assorted tropical fruit, wintergreen, cherry), other information (orange cream), 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.
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
- 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
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 (Image 01)
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 (Image 02)
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 (Image 03)
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 (Image 04)
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 (Image 05)
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 (Image 06)
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