Gdc Extra Strength Alkums Antacid 127af

Gdc Extra Strength Alkums Antacid 127af
SPL v2
SPL
SPL Set ID 1b6da4a3-cfa6-6d98-e063-6394a90a5889
Route
ORAL
Published
Effective Date 2024-08-13
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 D&c Red No. 27 Aluminum Lake D&c Red No. 30 Aluminum Lake D&c Yellow No. 10 Aluminum Lake Dextrose Fd&c Blue No. 1 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Magnesium Stearate Sucrose Talc Maltodextrin

Identifiers & Packaging

Pill Appearance
Imprint: G127 Shape: round Color: orange Color: green Color: yellow Color: pink Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-13

Description

Calcium carbonate 750 mg

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Calcium carbonate 750 mg

Use(s)

relieves:

acid indigestion 

heartburn

Warnings

.

Directions
  • adults  and children 12 years age and over:
  • wet in mouth before chewing 
  • 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
  • store at room temperature. Keep the container tightly closed.
Active Ingredient(s)

Calcium carbonate 750 mg

Inactive Ingradients

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

*Compare to the active ingredient in TUMS® EX

GUARDIAN ®

NDC 53041-102-22

Extra Strength

Alkums Antacid Tablets

Assorted Fruit Flavors

Calcium Carbonate 750 mg

Relieves :

  • Acid Indigestion
  • Heartburn

96 CHEWABLE TABLETS

*Compare to the active ingredient in TUMS® EX

GUARDIAN ®

NDC 53041-102-13

Extra Strength Alkums Antacid Tablets

Assorted Fruit Flavors

Calcium Carbonate 750 mg

Relieves :

  • Acid Indigestion
  • Heartburn

48 CHEWABLE TABLETS

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, under the advice and supervision of a doctor.

If Pregnancy/breast Feeding,

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

Use(s) (USE(S))

relieves:

acid indigestion 

heartburn

Purpose (PURPOSE)

Antacid

Warnings (WARNINGS)

.

Directions (DIRECTIONS)
  • adults  and children 12 years age and over:
  • wet in mouth before chewing 
  • 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
  • store at room temperature. Keep the container tightly closed.
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Calcium carbonate 750 mg

Inactive Ingradients (INACTIVE INGRADIENTS)

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® EX

GUARDIAN ®

NDC 53041-102-22

Extra Strength

Alkums Antacid Tablets

Assorted Fruit Flavors

Calcium Carbonate 750 mg

Relieves :

  • Acid Indigestion
  • Heartburn

96 CHEWABLE TABLETS

*Compare to the active ingredient in TUMS® EX

GUARDIAN ®

NDC 53041-102-13

Extra Strength Alkums Antacid Tablets

Assorted Fruit Flavors

Calcium Carbonate 750 mg

Relieves :

  • Acid Indigestion
  • Heartburn

48 CHEWABLE TABLETS

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, under the advice and supervision of a doctor.

If Pregnancy/breast Feeding, (IF PREGNANCY/BREAST-FEEDING,)

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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