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.

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

CALCIUM CARBONATE
calcium carbonate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0395-0431
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0395-0431-01	454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M001	01/01/2008

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Pharma Nobis, LLC (118564114)

Name	Address	ID/FEI	Business Operations
Establishment
Pharma Nobis, LLC		118564114	manufacture(0395-0431) , analysis(0395-0431) , pack(0395-0431) , label(0395-0431)

Humco Calcium Carbonate, USP