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Tums Dual Action

Dosage form: tablet, chewable
Ingredients: FAMOTIDINE 10mg, CALCIUM CARBONATE 800mg, MAGNESIUM HYDROXIDE 165mg
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0482

Drug Facts

Active ingredients

(in each chewable tablet)

Famotidine 10mg

Calcium carbonate 800mg

Magnesium hydroxide 165mg

Purpose

Acid reducer

Antacid

Antacid

Use

relieves heartburn associated with acid indigestion and sour stomach

Warnings

Allergy alert:

Do not use if you are allergic to famotidine or other acid reducers

Do not use
  • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See you doctor.
  • with other acid reducers

Ask a doctor before use if you have
  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • heartburn with lightheadedness, sweating, or dizziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

Ask a doctor or pharmacist before use if you are

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

Stop use and ask a doctor if
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • adults and children 12 years and over:
    • do not swallow tablet whole: chew completely
    • to relieve symptoms, chew 1 tablet before swallowing
    • do not use more than 2 chewable tablets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • each tablet contains: calcium 320mg; magnesium 65mg
  • Phenylketonurics: Contains Phenylalanine 2.2mg per tablet
  • read the directions and warnings before use
  • read the bottle label. It contains important information.
  • store at 20°-25°C (68°-77°F)
  • protect from moisture

Inactive ingredients

aspartame, D&C red no. 7 calcium, dextrates, FD&C blue no. 1 lake, FD&C red no. 40 lake, flavor, glyceryl monostearate, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

Questions or comments?

call toll-free 1-800-897-7535 (English/Spanish) weekdays

Principal Display Panel

TUMS

DUAL ACTION

Famotidine 10mg/Calcium Carbonate 800mg

Magnesium Hydroxide 165mg Tablets

ACID REDUCER+ANTACID

JUST ONE TABLET

relieves heartburn due to acid indigestion

50 CHEWABLE TABLETS

BERRY FLAVOR

Tips For Managing Heartburn

  • Do not lie flat or bend over after eating
  • Do not wear tight-fitting clothing around the stomach
  • Do not eat before bedtime
  • Raise the head of your bed
  • Avoid heartburn causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
  • Eat slowly and avoid big meals
  • If overweight, lose weight
  • Quit smoking

DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2008 GlaxoSmithKline

www.tums.com

62079XA

TUMS  DUAL ACTION
famotidine, calcium carbonate and magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0482
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
CALCIUM CARBONATE (CARBONATE ION and CALCIUM CATION) CALCIUM CARBONATE800 mg
MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE165 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
D&C RED NO. 7 
DEXTRATES 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
FD&C RED NO. 40 
GLYCERYL MONOSTEARATE 
ANHYDROUS LACTOSE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
POVIDONE 
TALC 
Product Characteristics
ColorPINK (light and dark pink) Scoreno score
ShapeROUNDSize18mm
FlavorBERRYImprint CodeTUMS;3
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0482-0125 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
2NDC:0135-0482-0250 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07735506/08/2011
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 01/2012
 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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