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NDC 30142-0164-38 citroma 1.745 g/29.6mL Details

citroma 1.745 g/29.6mL

citroma is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Krogers. The primary component is MAGNESIUM CITRATE.

Product Information

NDC	30142-0164
Product ID	30142-164_6b89c5dc-fc76-43a4-98fa-84a1fb540ecf
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	citroma
Proprietary Name Suffix	n/a
Non-Proprietary Name	Magnesium Citrate
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	1.745
Active Ingredient Units	g/29.6mL
Substance Name	MAGNESIUM CITRATE
Labeler Name	Krogers
Pharmaceutical Class	Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 30142-0164-38 (30142016438)

Pricing Information	N/A
NDC Package Code	30142-164-38
Billing NDC	30142016438
Package	296 mL in 1 BOTTLE, PLASTIC (30142-164-38)
Marketing Start Date	2018-02-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a87dceb2-da73-4d3a-b87c-db2af10471bf Details

Active Ingredient

Magnesium citrate 1.745g per fl oz

Purpose

Saline laxative

use

for relief of occasional constipation (irregularity).
Generally produces bowel movement in 1/2 to 6 hours

Warnings

for this product

Ask A Doctor

before use if you have

kidney disease
a magnesium restricted diet
abdominal pain, nausea, or vomiting
noticed a sudden change in bowel habits that persists over a period of 2 weeks
already used a laxative for a period longer than 1 week

Ask a doctor or pharmacist

before use if you are

taking any other drug.
Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use

and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

if pregnant or breast-feeding

ask health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away

Store at temperatures betweem 46° and 86°F (8° and 30° C)

Directions

drink a full glass (8 ounces) of liquid with each dose
may be taken as a single daily dose or in divided doses

adults and children 12 years of age and over - 6.5 to 10 fl oz maximum 10 fl oz in 24 hours

children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours

children 2 to under 6 years of age - 2 to 3 fl oz maximum 3 fl oz in 24 hours

children under 2 years of age - ask a doctor

other information

each fl oz contains: magnesium 290 mg
each fl oz contains: sodium 1 mg

Inactive ingredients

benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

QUALITY GUARANTEE

www.kroger.com

principal display panel

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRINGkROGER

Magnesium Citrate Oral Solution

SALINE LAXATIVE

Alcohol Content 0.0250% (from flavoring)

Pleasing Cherry Flavor

10 FL OZ (296 ml)

INGREDIENTS AND APPEARANCE

CITROMA

magnesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-164
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CITRATE	1.745 g in 29.6 mL

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SUCRALOSE (UNII: 96K6UQ3ZD4)
water (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:30142-164-38	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/18/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/18/2018

Labeler - Krogers (006999528)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(30142-164)

Revised: 8/2022

Document Id: 6b89c5dc-fc76-43a4-98fa-84a1fb540ecf

Set id: a87dceb2-da73-4d3a-b87c-db2af10471bf

Version: 15

Effective Time: 20220825