Label: CALCIUM CARBONATE powder
- NDC Code(s): 0395-0431-01
- Packager: Humco Holding Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated June 19, 2020
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- WHEN USING
- Ask a doctor before use
- Keep out of reach of children.
- Inactive Ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
calcium carbonate powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-0431 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 1 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0395-0431-01 454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/13/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 01/01/2008 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Humco Holding Group, Inc. (825672884) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc. 825672884 manufacture(0395-0431) , analysis(0395-0431) , pack(0395-0431) , label(0395-0431)