Drug Facts

Drug Facts
SPL v18
SPL
SPL Set ID 593a0494-d669-4bcf-8412-b92645b2d76c
Route
ORAL
Published
Effective Date 2014-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (750 mg)
Inactive Ingredients
Adipic Acid Starch, Corn Fd&c Blue No. 1 Aluminum Oxide Fd&c Red No. 40 Fd&c Yellow No. 5 Fd&c Yellow No. 6 Mineral Oil Sodium Polymetaphosphate Sucrose Talc Acacia Aspartame Calcium Stearate Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: TUMS Shape: round Color: pink Color: orange Color: yellow Color: green Color: red Color: blue Color: white Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-03-23 Until 2018-09-30

Description

Calcium Carbonate USP 750 mg

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Calcium Carbonate USP 750 mg

Uses

relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms
Directions
  • adults and children 12 years of age and over: chew 2 – 4 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
Questions?

1-800-897-7535

Do not use if printed inner safety seal under cap is broken or missing.

Gluten-Free

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

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
Inactive Ingredients (cherry)

adipic acid, corn starch, FD&C red #40 lake, flavor, mineral oil, sodium polyphosphate, sucrose, talc

Active Ingredient (per Tablet)

Calcium Carbonate USP 750 mg

Other Information (orange Cream)
  • each tablet contains: elemental calcium 300 mg
  • store below 30°C (86°F)

Phenylketonurics: Contains phenylalanine, less than 1mg per tablet.

Inactive Ingredients (wintergreen)

corn starch, FD&C blue #1 lake, FD&C yellow #5 (tartrazine) lake, flavor, mineral oil, sodium polyphosphate, sucrose, talc

Other Information (assorted Fruit)
  • each tablet contains: elemental calcium 305 mg, magnesium 5 mg, sodium 2mg
  • store below 30°C (86°F)
  • contains FD&C Yellow No. 5 (tartrazine) as a color additive
Other Information (assorted Berries)
  • each tablet contains: elemental calcium 305 mg, magnesium 5 mg, sodium 2mg
  • store below 30°C (86°F)
Inactive Ingredients (assorted Fruit)

adipic acid, corn starch, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum 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

Principal Display Panel (assorted Fruit)

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Assorted Fruit

96 CHEWABLE TABLETS

EXTRA STRENGTH 750

Principal Display Panel (assorted Berries)

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Assorted Berries

96 CHEWABLE TABLETS

EXTRA STRENGTH 750

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 (sugar Free Orange Cream)

acacia, adipic acid, aspartame, calcium stearate, FD&C yellow #6 lake, flavors, sorbitol

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Other Information (assorted Tropical Fruit, Wintergreen, Cherry)
  • each tablet contains: elemental calcium 300 mg, sodium 2 mg
  • store below 30°C (86°F)

Structured Label Content

Uses

relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms
Purpose

Antacid

Directions
  • adults and children 12 years of age and over: chew 2 – 4 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
Questions?

1-800-897-7535

Do not use if printed inner safety seal under cap is broken or missing.

Gluten-Free

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

When Using This Product (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
Inactive Ingredients (cherry) (Inactive ingredients (Cherry))

adipic acid, corn starch, FD&C red #40 lake, flavor, mineral oil, sodium polyphosphate, sucrose, talc

Active Ingredient (per Tablet) (Active ingredient (per tablet))

Calcium Carbonate USP 750 mg

Other Information (orange Cream) (Other information (Orange Cream))
  • each tablet contains: elemental calcium 300 mg
  • store below 30°C (86°F)

Phenylketonurics: Contains phenylalanine, less than 1mg per tablet.

Inactive Ingredients (wintergreen) (Inactive ingredients (Wintergreen))

corn starch, FD&C blue #1 lake, FD&C yellow #5 (tartrazine) lake, flavor, mineral oil, sodium polyphosphate, sucrose, talc

Other Information (assorted Fruit) (Other information (Assorted Fruit))
  • each tablet contains: elemental calcium 305 mg, magnesium 5 mg, sodium 2mg
  • store below 30°C (86°F)
  • contains FD&C Yellow No. 5 (tartrazine) as a color additive
Other Information (assorted Berries) (Other information (Assorted Berries))
  • each tablet contains: elemental calcium 305 mg, magnesium 5 mg, sodium 2mg
  • store below 30°C (86°F)
Inactive Ingredients (assorted Fruit) (Inactive ingredients (Assorted Fruit))

adipic acid, corn starch, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc

Inactive Ingredients (assorted Berries) (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

Principal Display Panel (assorted Fruit) (Principal Display Panel (Assorted Fruit))

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Assorted Fruit

96 CHEWABLE TABLETS

EXTRA STRENGTH 750

Principal Display Panel (assorted Berries) (Principal Display Panel (Assorted Berries))

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Assorted Berries

96 CHEWABLE TABLETS

EXTRA STRENGTH 750

Inactive Ingredient (assorted Tropical Fruit) (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 (sugar Free Orange Cream) (Inactive ingredients (Sugar Free Orange Cream))

acacia, adipic acid, aspartame, calcium stearate, FD&C yellow #6 lake, flavors, sorbitol

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Other Information (assorted Tropical Fruit, Wintergreen, Cherry) (Other information (Assorted Tropical Fruit, Wintergreen, Cherry))
  • each tablet contains: elemental calcium 300 mg, sodium 2 mg
  • store below 30°C (86°F)

Advanced Ingredient Data


Raw Label Data

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