TUMS- calcium carbonate   
GlaxoSmithKline Consumer Heathcare LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (per tablet) (Ultra)

Calcium carbonate USP 1,000 mg

Active ingredient (per tablet) (Freshers)

Calcium carbonate USP 500 mg

Purpose

Antacid

Uses

relieves

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

Warnings

Ask a doctor or pharmacist before use if you are

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

When using this product (Ultra)

•
do not take more than 7 tablets in 24 hours
•
do not use the maximum dosage for more than 2 weeks

When using this product (Freshers)

•
do not take more than 15 tablets in 24 hours
•
do not use the maximum dosage for more than 2 weeks

Keep out of reach of children.

Directions (Ultra)

•
chew 2-3 tablets as symptoms occur, or as directed by a doctor

Directions (Freshers)

•
take 2-4 tablets as symptoms occur, or as directed by a doctor

Other information (Ultra)

•
for calcium and sodium content see Supplement Facts
•
store below 30oC (86oF)

Other information (Freshers)

•
each tablet contains: elemental calcium 200 mg
•
store below 25°C (77°F)

Inactive ingredients (Ultra)

sucrose, calcium carbonate, corn starch, talc, mineral oil, natural and artificial flavors, adipic acid, sodium polyphosphate, red 40 lake, yellow 6 lake, yellow 5 (tartrazine) lake, blue 1 lake

Inactive ingredients (Assorted Tropical Fruit)

calcium stearate, corn starch, FD&C Blue #1, gum acacia, maltodextrin, natural & artificial flavor, sorbitol, sucralose, sucrose, tocopherols

Questions? (Ultra)

1-800-897-7535 weekdays

CALCIUM SUPPLEMENT

USES: As a daily source of extra calcium.

DIRECTIONS: Chew 2 tablets once or twice daily with a meal.

Supplement Facts

Serving Size: 2 Tablets

Servings Per Container: 80

Amount Per Serving

% Daily Value

Calories 10

Sugars 3g

Calcium 800mg

80%

Sodium 10mg

(less than 1%)

Safety sealed- Do not use if printed inner seal beneath cap is missing or broken.

Gluten-Free

PAREVE

Questions or Comments? (Freshers)

1-800-897-7535 (English/Spanish) weekdays

Safety sealed- Do not use if printed inner seal beneath cap is missing or broken.

Gluten-Free

If using this product as a calcium supplement, do not exceed 5 tablets per day without consulting a doctor.

TUMS®, FRESHERS® and other marks are trademarks of the GlaxoSmithKline group of companies.

PAREVE

Principal Display Panel

NDC 0135-0543-01

TUMS®

freshers

CALCIUM RICH

ANTACID

cool mint

TUMS®

ANTACID/CALCIUM SUPPLEMENT

ULTRA STRENGTH 1000

ASSORTED FRUIT

NATURALLY & ARTIFICIALLY FLAVORED

Special Pack

1-25 ct FRESHERS

1-160 ct ASSORTED FRUIT

CHEWABLE TABLETS

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

www.tums.com

FIGHT BACK FAST WITH TUMS + Fast Heartburn Relief, Fresh Breath

ANYTIME, ANYWHERE.

Use as directed.

©2012 GlaxoSmithKline

102322PB

Tums Ultra 160 count & Freshers 25 count carton
TUMS 
calcium carbonate kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0543
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0543-011 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 160 
Part 21 BOTTLE 25 
Part 1 of 2
TUMS  ULTRA
calcium carbonate tablet, chewable
Product Information
Item Code (Source)NDC:0135-0118
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE1000 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE 
STARCH, CORN 
TALC 
MINERAL OIL 
ADIPIC ACID 
SODIUM POLYMETAPHOSPHATE 
FD&C RED NO. 40 
ALUMINUM OXIDE 
FD&C YELLOW NO. 6 
FD&C YELLOW NO. 5 
FD&C BLUE NO. 1 
Product Characteristics
ColorPINK (orange, yellow, green) Scoreno score
ShapeROUNDSize19mm
FlavorCHERRY (assorted fruit, orange, lemon, lime) Imprint Code TUMS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0118-14160 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33102/12/2010
Part 2 of 2
TUMS  FRESHERS
calcium carbonate tablet, chewable
Product Information
Item Code (Source)NDC:0135-0522
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE500 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM STEARATE 
STARCH, CORN 
FD&C BLUE NO. 1 
ACACIA 
MALTODEXTRIN 
SORBITOL 
SUCRALOSE 
SUCROSE 
TOCOPHEROL 
Product Characteristics
ColorWHITE (with blue speckles) Scoreno score
ShapeOVALSize13mm
FlavorPEPPERMINT (cool mint) Imprint Code TUMS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0522-021 in 1 CARTON
125 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33102/02/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33109/14/201202/28/2014
Labeler - GlaxoSmithKline Consumer Heathcare LP (828924212)

Revised: 1/2014
Document Id: 71dddc99-14c6-42da-a44d-9ad1ea5c487b
Set id: 2a1e77a5-f792-4c91-aaba-3671b618a366
Version: 2
Effective Time: 20140123
 
GlaxoSmithKline Consumer Heathcare LP