family wellness extra strength assorted fruit antacid_127af

family wellness extra strength assorted fruit antacid_127af
SPL v1
SPL
SPL Set ID 96a711b5-3603-4a0c-80ae-be9ccfe35d16
Route
oral
Published
Effective Date 2024-02-20
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
calcium cation (750 mg)
Inactive Ingredients
adipic acid starch, corn crospovidone, unspecified dextrose, unspecified form fd&c blue no. 1 magnesium stearate maltodextrin sucrose talc d&c red no. 27 d&c red no. 30 d&c yellow no. 10 fd&c yellow no. 6

Identifiers & Packaging

Pill Appearance
Imprint: G127 Shape: round Color: orange Color: yellow Color: green Color: pink Size: 16 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-02-20

Purpose

Antacid

Description

Calcium carbonate 750 mg


Medication Information

Warnings

.

Active Ingredient

Calcium carbonate 750 mg

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.
Other Information
  • each tablet contains: elemental calcium 300 mg, magnesium 10 mg
  • do not use if printed seal under cap is torn or missing. 
  • store at room temperature. Keep the container tightly closed.
Inactive Ingredients

adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

Description

Calcium carbonate 750 mg

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN TUMS® EXTRA STRENGTH* 



EXTRA STRENGTH

ANTACID TABLETS

Calcium Carbonate 750 mg

ASSORTED FRUIT FLAVORS

NDC 55319-127-22

96 CHEWABLE TABLETS



  



Use(s)

relieves:

  • acid indigestion
  • heartburn
When Using This Product

do not take more than 10 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

If Pregnant Or/breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

.

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

Warnings (WARNINGS)

.

Active Ingredient (ACTIVE INGREDIENT (in each tablet))

Calcium carbonate 750 mg

Purpose (PURPOSE)

Antacid

Directions (DIRECTIONS)
  • adults and children 12 years of age and over:
  • chew 2-4 tablets as symptoms occur, or as directed by a doctor.
Other Information (OTHER INFORMATION)
  • each tablet contains: elemental calcium 300 mg, magnesium 10 mg
  • do not use if printed seal under cap is torn or missing. 
  • store at room temperature. Keep the container tightly closed.
Inactive Ingredients (INACTIVE INGREDIENTS)

adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO THE ACTIVE INGREDIENT IN TUMS® EXTRA STRENGTH* 



EXTRA STRENGTH

ANTACID TABLETS

Calcium Carbonate 750 mg

ASSORTED FRUIT FLAVORS

NDC 55319-127-22

96 CHEWABLE TABLETS



  



Use(s) (USE(S))

relieves:

  • acid indigestion
  • heartburn
When Using This Product (WHEN USING THIS PRODUCT)

do not take more than 10 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

If Pregnant Or/breastfeeding, (IF PREGNANT OR/BREASTFEEDING,)

ask a health professional before use.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

.

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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