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NDC 00904-6787-44 Saline Laxative 1.745 g/29.6mL Details

Saline Laxative 1.745 g/29.6mL

Saline Laxative is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is MAGNESIUM CITRATE.

MedlinePlus Drug Summary

Magnesium citrate is used to treat occasional constipation on a short-term basis. Magnesium citrate is in a class of medications called saline laxatives. It works by causing water to be retained with the stool. This increases the number of bowel movements and softens the stool so it is easier to pass.

Related Packages: 00904-6787-44
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Magnesium Citrate

Product Information

NDC	00904-6787
Product ID	0904-6787_1234ebe2-b47c-4fd6-adb7-d7eb8985e48b
Associated GPIs	46100020102000
GCN Sequence Number	003025
GCN Sequence Number Description	magnesium citrate SOLUTION ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09240
HICL Sequence Number	001328
HICL Sequence Number Description	MAGNESIUM CITRATE
Brand/Generic	Generic
Proprietary Name	Saline Laxative
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	Major Pharmaceuticals
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 00904-6787-44 (00904678744)

Pricing Information
NDC Package Code	0904-6787-44
Billing NDC	00904678744
Package	296 mL in 1 BOTTLE, PLASTIC (0904-6787-44)
Marketing Start Date	2018-02-18
NDC Exclude Flag	N
Price Per Unit	0.0069
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	MAGNESIUM CITRATE SOLUTION
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 66bcbfe8-5b75-4105-899d-d969700aecfe 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 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 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 295 mg
each fl oz contains: sodium 1 mg

Inactive ingredients

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

Questions or comments?

(800)616-2471

principal display panel

MAJOR

Magnesium Citrate

Saline Laxative

Lemon Flavored

Alcohol content 0.012% from flavoring

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

10 FL OZ (296 mL)

INGREDIENTS AND APPEARANCE

SALINE LAXATIVE

magnesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6787
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:0904-6787-44	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 - Major Pharmaceuticals (191427277)

Registrant - Vi-Jon, Inc (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, Inc		790752542	manufacture(0904-6787)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, Inc		088520668	manufacture(0904-6787)

Revised: 9/2022

Document Id: 1234ebe2-b47c-4fd6-adb7-d7eb8985e48b

Set id: 66bcbfe8-5b75-4105-899d-d969700aecfe

Version: 11

Effective Time: 20220906