SALINE LAXATIVE- magnesium citrate liquid 
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Magnesium Citrate
166.000/164 rev 1-166AB

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

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

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

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)

image description

SALINE LAXATIVE 
magnesium citrate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6787
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE1.745 g  in 29.6 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6787-44296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/18/2018
Labeler - Major Pharmaceuticals (191427277)
Registrant - Vi-Jon, Inc (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, Inc790752542manufacture(0904-6787)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, Inc088520668manufacture(0904-6787)

Revised: 9/2022
Document Id: 1234ebe2-b47c-4fd6-adb7-d7eb8985e48b
Set id: 66bcbfe8-5b75-4105-899d-d969700aecfe
Version: 11
Effective Time: 20220906
 
Major Pharmaceuticals