CALCIUM CARBONATE powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)

Available from:

Humco Holding Group, Inc.

INN (International Name):

CALCIUM CARBONATE

Composition:

CALCIUM CATION 1 g in 1 g

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antacid For relief of heartburn, acid ingestion, and upset stomach associated with these symptoms. if you are preganant or nursing a baby.

Authorization status:

OTC monograph final

Summary of Product characteristics

CALCIUM CARBONATE- CALCIUM CARBONATE POWDER
HUMCO HOLDING GROUP, INC.
----------
HUMCO CALCIUM CARBONATE, USP
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
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION -
UNII:2M83C4R6Z B)
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
Humco Holding Group, Inc.
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M001
01/01/2008
LABELER -
Humco Holding Group, Inc. (825672884)
REGISTRANT -
Pharma Nobis, LLC (118564114)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Pharma Nobis,
LLC
118564114
manufacture(0395-0431) , analysis(0395-0431) , pack(0395-0431) ,
label(0395-0431)
Revised: 12/2023