CITROMA- magnesium citrate liquid 
Vi Jon, LLC

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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Swan 667

Active ingredient

Magnesium citrate

Purpose

Saline laxative

Use

for relief of occasional constipation (irregularity).  Generally produces bowel movement in 1/2 to 6 hours

Warnings

for this product

Do not use

  • if you are on a low salt diet

Ask a doctor before use if you have

  • kidney disease
  • a magnesium or sodium-restricted diet
  • abdominal 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

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 temperatures between 46⁰ and 86⁰F (8⁰ and 30⁰ 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 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

discard unused product within 24 hours of opening bottle

Other information

  • each fl oz contains: magnesium 290 mg
  • each fl oz contains: sodium 45 mg

Inactive ingredients

citric acid, lemon oil, polyethylene glycol, purified water, sodium bicarbonate, sodium saccharin, sucrose

Adverse reactions section

Distributed by:

Vi-Jon

One Swan Drive

Smyrna, TN 37167

principal display panel

NDC 0869-0667-38

SWAN

Citroma

MAGNESIUM CITRATE

lemony

  • Oral Solution
  • Saline Laxative
  • Pasturized
  • The sparkling Laxative

Do not use if tamper evident tist-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:0869-0667
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LEMON OIL (UNII: I9GRO824LL)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
water (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0869-0667-38296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/15/198908/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/15/198908/16/2022
Labeler - Vi Jon, LLC (790752542)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(0869-0667)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(0869-0667)

Revised: 8/2022
 
Vi Jon, LLC