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NDC 41250-0708-38 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 Meijer Distribution, Inc. The primary component is MAGNESIUM CITRATE.

Product Information

NDC	41250-0708
Product ID	41250-708_64664e5f-d91d-4cb4-9fce-4bf8abee4134
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	Meijer Distribution, Inc
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 41250-0708-38 (41250070838)

Pricing Information	N/A
NDC Package Code	41250-708-38
Billing NDC	41250070838
Package	296 mL in 1 BOTTLE, PLASTIC (41250-708-38)
Marketing Start Date	2018-02-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 58855261-1d2a-47c6-bbf1-26d4a717d778 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
abdorominal 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 help 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 between 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 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 in 24 hours

children under 2 years of age - ask a doctor

other information

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

Inactive ingredients

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

Adverse Reaction

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

principal display panel

Do not use if tamper evident twist-off cap is missing, broken or separated from neckring

meijer

Lemon Flavor

Magnesium

Citrate

Oral Solution U.S.P.

Saline Laxative

Sugar Free/Low Sodium

Relief of occasional constipation

Contains no ingredient made from gluten-containing grain (wheat, barley or rye)

Alcohol content 0.012% (from flavoring)

10 FL OZ (296 mL)

INGREDIENTS AND APPEARANCE

CITROMA

magnesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-708
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-708-38	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 - Meijer Distribution, Inc (006959555)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(41250-708)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(41250-708)

Revised: 4/2022

Document Id: 64664e5f-d91d-4cb4-9fce-4bf8abee4134

Set id: 58855261-1d2a-47c6-bbf1-26d4a717d778

Version: 11

Effective Time: 20220406