CALCIUM CARBONATE powder

Calcium Carbonate by

Drug Labeling and Warnings

Calcium Carbonate by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Calcium Carbonate

Purpose

Antacid

Use

For relief of heartburn, acid ingestion, and upset stomach associated with these symptoms.

Warnings

Except under the supervision of a doctor:

• do not administer to children under 6 years of age.
• do not take more than 3 teaspoonfuls in a 24 hour period.

WHEN USING

• do not use the maximum dosge of this product for more than 2 weeks except under the advice and supervision of a doctor or other health professional.

Ask a doctor before use

if you are preganant or nursing a baby.

Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control immediately.

Directions

Adults and children 6 yrs. of age and older: Take 1/2 level tsp. in 1/2 glass (4 fl oz) of water every 2 hrs. up to maximum dosage or as directed by a doctor.

Inactive Ingredients

None

Principal Display Panel

INGREDIENTS AND APPEARANCE

CALCIUM CARBONATE 
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)