CITROMA- magnesium citrate liquid 
Vi-Jon, Inc

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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Drug Facts

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 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 betweem 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

Adverse Reaction

Distributed by: Vi-Jon, Inc.

One Swan Drive,

Smyrna, TN 37167

164.000/164AA

princpal display panel

SWAN

VERY LOW SODIUM

Citroma

MAGNESIUM CITRATE

cherry

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

10 FL OZ (296 mL)

image description

CITROMA 
magnesium citrate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0164
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:0869-0164-38296 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 - Vi-Jon, Inc (790752542)
Registrant - Vi-Jon, Inc (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, Inc790752542manufacture(0869-0164)

Revised: 8/2019
Document Id: 7cf84164-ad68-45dd-9d52-364d4a69eab1
Set id: e0fc85be-1ad1-4f2e-8635-31e2d56fb2b4
Version: 2
Effective Time: 20190821
 
Vi-Jon, Inc