MAGNESIUM CITRATE- magnesium citrate solution 
H E Butt

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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Lemon Magnesium Citrate
166.000/166AA rev 1-AB

Active ingredient

Active ingredient (in each fl oz) 

Magnesium citrate 1.745 g

purpose

Saline Laxative   

Uses

Warnings

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 durgs 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 a 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 temperature between 46° and 86°F (8° abd 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 maximum 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

Call 1-88-593-0593

Adverse reaction

MADE WITH PRIDE & CARE FOR H-E-B

SAN ANTONIO, TN 78204

Principal Panel Display

H-E-B

Magnesium Citrate

Oral solution

saline Laxative

Sugar & dye free

Gluten Free

Lemon Flavor

10 FL OZ (296 mL)

Do Not Use If Tamper Evident Twist-off Cap Is Missing, Broken or Separated From Neckring

image description

MAGNESIUM CITRATE 
magnesium citrate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-769
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE0.059 g  in 1 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:37808-769-38296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/07/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/07/2021
Labeler - H E Butt (007924756)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(37808-769)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(37808-769)

Revised: 9/2022
Document Id: dabc14e4-440e-4d58-88a2-e1fdca6d3ed9
Set id: 91e2cf68-c61d-46d5-b9ce-c1b01fca1fcc
Version: 19
Effective Time: 20220919
 
H E Butt