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  5. Label Information: Calcium Carbonate

FDA Label for Calcium Carbonate

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL)
    3. PURPOSE
    4. USES
    5. OTC - ASK DOCTOR/PHARMACIST
    6. OTC - WHEN USING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. PRINCIPAL DISPLAY PANEL - 473 ML BOTTLE LABEL
    13. PRINCIPAL DISPLAY PANEL - 5 ML CUP LABEL

Calcium Carbonate Product Label

The following document was submitted to the FDA by the labeler of this product Pai Holdings, 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.

Other



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

Otc - Ask Doctor/Pharmacist



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


Otc - When Using



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.


Otc - Keep Out Of Reach Of Children



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° to 25°C (68° to 77°F)
  • do not freeze
  • packaged with tamper evident seal

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?



Call 1-800-845-8210.


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)

pai
Pharmaceutical
Associates, Inc.
Greenville, SC 29605


Principal Display Panel - 5 Ml Cup 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

FOR INSTITUTIONAL USE ONLY
 PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT

A47660500


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