Calcium Carbonate

Calcium Carbonate
SPL v8
SPL
SPL Set ID d89f3184-7081-4e16-a504-9214283891f6
Route
ORAL
Published
Effective Date 2023-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (1250 mg)
Inactive Ingredients
D&c Red No. 33 Saccharin Calcium Water Propylparaben Methylparaben Propylene Glycol Sorbitol Glycerin Xanthan Gum Anhydrous Citric Acid Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-12-01

Description

Drug Facts

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Drug Facts

Uses

Relieves:

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product, do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

Directions
  • Shake well before using.
  • Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.
Other Information
  • store at 20° - 25°C (68° - 77°F)
  • do not freeze
  • Calcium Carbonate Oral Suspension is a pink-colored, bubble gum flavored suspension supplied in the following oral dosage forms:
NDC 0121-0766-16: 16 fl oz (473 mL) bottle
NDC 0121-4766-05: 5 mL unit dose cup, in a tray of ten cups.
Inactive Ingredients

calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.

Questions Or Comments?

Call 1-800-845-8210.

You may also report serious side effects to this phone number.

Active Ingredient (in Each 5 Ml Teaspoonful)

Calcium Carbonate 1250 mg

(Equivalent to 500 mg elemental Calcium)

Principal Display Panel 473 Ml Bottle Label

NDC 0121-0766-16

Quality ®

Value

Calcium Carbonate

Oral Suspension

1250 mg/5 mL

Maximum Strength

ANTACID

Daily source of calcium

SUGAR FREE / ALCOHOL FREE

SODIUM FREE

16 fl oz (473 mL)

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

Principal Display Panel 5 Ml Cup Tray Label

Delivers 5 mL

NDC 0121-4766-05

Calcium Carbonate Oral Suspension



1250 mg/5 mL

(equivalent to 500 mg of elemental Calcium)

ANTACID – SHAKE WELL

Package Not Child-Reistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

SEE INSERT

A0766051021


Structured Label Content

Uses

Relieves:

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product, do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

Purpose

Antacid

Directions
  • Shake well before using.
  • Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.
Other Information (Other information)
  • store at 20° - 25°C (68° - 77°F)
  • do not freeze
  • Calcium Carbonate Oral Suspension is a pink-colored, bubble gum flavored suspension supplied in the following oral dosage forms:
NDC 0121-0766-16: 16 fl oz (473 mL) bottle
NDC 0121-4766-05: 5 mL unit dose cup, in a tray of ten cups.
Inactive Ingredients (Inactive ingredients)

calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.

Questions Or Comments? (Questions or comments?)

Call 1-800-845-8210.

You may also report serious side effects to this phone number.

Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL teaspoonful))

Calcium Carbonate 1250 mg

(Equivalent to 500 mg elemental Calcium)

Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

NDC 0121-0766-16

Quality ®

Value

Calcium Carbonate

Oral Suspension

1250 mg/5 mL

Maximum Strength

ANTACID

Daily source of calcium

SUGAR FREE / ALCOHOL FREE

SODIUM FREE

16 fl oz (473 mL)

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

Principal Display Panel 5 Ml Cup Tray Label (PRINCIPAL DISPLAY PANEL - 5 mL Cup Tray Label)

Delivers 5 mL

NDC 0121-4766-05

Calcium Carbonate Oral Suspension



1250 mg/5 mL

(equivalent to 500 mg of elemental Calcium)

ANTACID – SHAKE WELL

Package Not Child-Reistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

SEE INSERT

A0766051021


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)