Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 189850d0-6f06-45bd-bd7e-9063ee580d0b
Route
ORAL
Published
Effective Date 2014-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (1177 mg)
Inactive Ingredients
Starch, Corn Corn Syrup Fd&c Blue No. 1 Glycerin Acacia Hydrogenated Coconut Oil Cow Milk Potassium Sorbate Propylene Glycol Lecithin, Soybean Sucrose Fd&c Red No. 40 Aluminum Oxide Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: white Color: pink Color: orange Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-08-15

Description

Calcium carbonate USP 1177 mg

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Calcium carbonate USP 1177 mg

Uses

Relieves:

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms
Directions
  • adults and children 12 years of age and over:chew and swallow 2-3 chews 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 chew contains:elemental calcium 470 mg, magnesium 5 mg
  • do not store above 25°C (77°F)
Questions Or Comments?

1-800-897-7535 weekdays

Principal Display Panel

NDC 0135-0561-01

TUMS ®

CALCIUM CARBONATE

ANTACID

Chewy Delights ®

Smooth Peppermint

ULTRA STRENGTH

GOES TO WORK IN SECONDS!

32SOFT CHEWS INDIVIDUALLY WRAPPED

FAST & TASTY

HEARTBURN RELIEF

DAIRY

Tamper Evident:Do not use if packaging is torn or damaged.

Distributed By:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

TUMS and logo device are trademarks of the GSK group of companies.

©2014 GSK group of companies.

All Rights Reserved

103608XA

When Using This Product
  • do not take more than 6 chews in 24 hours
  • if pregnant, do not take more than 4 chews in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
Active Ingredient (in Each Chew)

Calcium carbonate USP 1177 mg

Inactive Ingredients (orange Rush)

corn starch, corn syrup, corn syrup solids, FD&C yellow #6 lake, flavors, glycerin, hydrogenated coconut oil, modified food starch, non-fat dairy milk, propylene glycol, soy lecithin, sucrose

Inactive Ingredients (very Cherry)

corn starch, corn syrup, corn syrup solids, FD&C red #40 lake, flavors, glycerin, hydrogenated coconut oil, non-fat dairy milk, propylene glycol, soy lecithin, sucrose

Inactive Ingredients (smooth Peppermint)

corn starch, corn syrup, corn syrup solids, FD&C blue #1, flavors, glycerin, gum arabic, hydrogenated coconut oil, non-fat dairy milk, potassium sorbate, propylene glycol, soy lecithin, sucrose

Ask A Doctor Or Pharmacist Before Use If You Are

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


Structured Label Content

Uses

Relieves:

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

Antacid

Directions
  • adults and children 12 years of age and over:chew and swallow 2-3 chews 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 (Other information)
  • each chew contains:elemental calcium 470 mg, magnesium 5 mg
  • do not store above 25°C (77°F)
Questions Or Comments? (Questions or Comments?)

1-800-897-7535 weekdays

Principal Display Panel

NDC 0135-0561-01

TUMS ®

CALCIUM CARBONATE

ANTACID

Chewy Delights ®

Smooth Peppermint

ULTRA STRENGTH

GOES TO WORK IN SECONDS!

32SOFT CHEWS INDIVIDUALLY WRAPPED

FAST & TASTY

HEARTBURN RELIEF

DAIRY

Tamper Evident:Do not use if packaging is torn or damaged.

Distributed By:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

TUMS and logo device are trademarks of the GSK group of companies.

©2014 GSK group of companies.

All Rights Reserved

103608XA

When Using This Product (When using this product)
  • do not take more than 6 chews in 24 hours
  • if pregnant, do not take more than 4 chews in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
Active Ingredient (in Each Chew) (Active ingredient (in each chew))

Calcium carbonate USP 1177 mg

Inactive Ingredients (orange Rush) (Inactive ingredients (Orange Rush))

corn starch, corn syrup, corn syrup solids, FD&C yellow #6 lake, flavors, glycerin, hydrogenated coconut oil, modified food starch, non-fat dairy milk, propylene glycol, soy lecithin, sucrose

Inactive Ingredients (very Cherry) (Inactive ingredients (Very Cherry))

corn starch, corn syrup, corn syrup solids, FD&C red #40 lake, flavors, glycerin, hydrogenated coconut oil, non-fat dairy milk, propylene glycol, soy lecithin, sucrose

Inactive Ingredients (smooth Peppermint) (Inactive ingredients (Smooth Peppermint))

corn starch, corn syrup, corn syrup solids, FD&C blue #1, flavors, glycerin, gum arabic, hydrogenated coconut oil, non-fat dairy milk, potassium sorbate, propylene glycol, soy lecithin, sucrose

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.


Advanced Ingredient Data


Raw Label Data

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