calcium carbonate

Drug Facts

Composition & Product

Active Ingredients

carbonate ion (1250 mg)

Inactive Ingredients

propylparaben methylparaben propylene glycol sorbitol glycerin xanthan gum citric acid monohydrate fd&c red no. 40 d&c red no. 33 saccharin calcium water

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

otc monograph final active Since 2004-12-01

Medication Information

Uses

Relieves:

heartburn
acid indigestion
sour stomach
upset stomach associated with these symptoms

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

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.

Description

Drug Facts

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.

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 5 Ml Cup Tray Label

NDC 81646-112-05

Calcium Carbonate Oral

Suspension

Maximum Strength

1250 mg/5 mL

(equivalent to 500 mg of elemental Calcium)

SUGAR FREE/ ALCOHOL FREE/ SODIUM FREE

ANTACID – SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

This unit-dose package is not child-resistant.

Store at 20° - 25°C (68° - 77°F)

10 x 5 mL Unit-Dose Cups

Pinnacle Pharma LLC

Charlotte, NC 28217

Case Label

Cup Label

Structured Label Content

Uses

Relieves:

heartburn
acid indigestion
sour stomach
upset stomach associated with these symptoms

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.

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.

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

NDC 81646-112-05

Calcium Carbonate Oral

Suspension

Maximum Strength

1250 mg/5 mL

(equivalent to 500 mg of elemental Calcium)

SUGAR FREE/ ALCOHOL FREE/ SODIUM FREE

ANTACID – SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

This unit-dose package is not child-resistant.

Store at 20° - 25°C (68° - 77°F)

10 x 5 mL Unit-Dose Cups

Pinnacle Pharma LLC

Charlotte, NC 28217

Case Label

Cup Label

Advanced Ingredient Data

[{"name": "CARBONATE ION", "unii": "7UJQ5OPE7D", "classCode": "ACTIB", "strengthNumerator": "1250", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN CALCIUM", "unii": "5101OP7P2I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Relieves: heartburn acid indigestion sour stomach upset stomach associated with these symptoms", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "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.", "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": "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 - 5 mL Cup Tray Label": "NDC 81646-112-05 Calcium Carbonate Oral Suspension Maximum Strength 1250 mg/5 mL (equivalent to 500 mg of elemental Calcium) SUGAR FREE/ ALCOHOL FREE/ SODIUM FREE ANTACID – SHAKE WELL USUAL DOSAGE: See attached Drug Facts This unit-dose package is not child-resistant. Store at 20° - 25°C (68° - 77°F) 10 x 5 mL Unit-Dose Cups Pinnacle Pharma LLC Charlotte, NC 28217 Case Label Cup Label"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information