Label: CALCIUM CARBONATE ORAL SUSPENSION- calcium carbonate suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 0904-6842-94 - Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 14, 2020
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Major Pharmaceuticals
Calcium Carbonate Oral Suspension, USP
5 mL unit dose cup
NDC 0904-6842-94
Calcium Carbonate
Oral Suspension, USP
1250 mg/5 mL
(equivalent to 500 mg of elemental Calcium)
Delivers 5 mL
Antacid - Shake Well
See Insert
For Institutional Use Only
Major Pharmaceuticals
Livonia, MI 48152
Sugar Free - Alcohol Free
Calcium Carbonate Oral Suspension
Directions
- do not exceed the maximum recommended daily dose in a 24-hour period
- do not use the maximum dosage for more than 2 weeks
- shake well before use
Dose (mL)
5-10 mL as symptoms occur
Do not take more than 30 mL in 24 hours.
Calcium Carbonate Oral Solution
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Calcium Carbonate Oral Solution
Warnings
Ask a doctor or pharmacist before use if you are taking any other drug. Antacids may interact with certain prescription drugs.
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If pregnant or breast-feeding, ask a health professional before use.
Calcium Carbonate Oral Solution
Inactive ingredients cherry flavor, citric acid, glycerin, methyl cellulose, methyl paraben, propyl paraben, purified water, sorbitol, sucralose, xanthan gum.
Calcium Carbonate Oral Solution
Active ingredient (in each 5 mL cup)
Calcium Carbonate 1250 mg
(Equivalent to 500 mg elemental Calcium)
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INGREDIENTS AND APPEARANCE
CALCIUM CARBONATE ORAL SUSPENSION
calcium carbonate suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6842 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 1250 mg in 5 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H) SORBITOL (UNII: 506T60A25R) Product Characteristics Color white Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-6842-94 10 in 1 CASE 01/02/2020 03/02/2020 1 10 in 1 TRAY 1 5 mL in 1 CUP; 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 01/02/2020 Labeler - Major Pharmaceuticals (191427277) Registrant - Plastikon Healthcare (041717941) Establishment Name Address ID/FEI Business Operations Plastikon Healthcare, LLC 041717941 manufacture(0904-6842)
