FDA Label for Calcium Carbonate
View Indications, Usage & Precautions
Calcium Carbonate Product Label
The following document was submitted to the FDA by the labeler of this product Pinnacle Pharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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.
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
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