CALCIUM CARBONATE suspension

Calcium Carbonate by

Drug Labeling and Warnings

Calcium Carbonate by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Associates, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Calcium Carbonate 1250 mg
(Equivalent to 500 mg elemental Calcium)

Purpose

Antacid

Uses

Relieves:

• heartburn
• acid indigestion
• sour stomach
• upset stomach associated with these symptoms

Warnings

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

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.

Keep out of reach of children.

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. Case contains 40 unit dose cups of 5 mL packaged in 4 trays of 10 unit dose cups each.

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.

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MANUFACTURED BY

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

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

NDC: 0121-4766-05

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

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

T4766050218
R02/18

INGREDIENTS AND APPEARANCE

CALCIUM CARBONATE 
calcium carbonate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-0766
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	1250 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SACCHARIN CALCIUM (UNII: 5101OP7P2I)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-0766-16	12 in 1 CASE	12/01/2004
1		473 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	12/01/2004

CALCIUM CARBONATE 
calcium carbonate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-4766
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	1250 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SACCHARIN CALCIUM (UNII: 5101OP7P2I)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-4766-05	4 in 1 CASE	12/01/2004
1		10 in 1 TRAY
1		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	12/01/2004

Labeler - Pharmaceutical Associates, Inc. (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Associates, Inc.		097630693	manufacture(0121-0766, 0121-4766)