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

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

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

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

667.001/667AG

Principal display panel

NDC 0869-0667-38

SWAN

Citroma

MAGNESIUM CITRATE

lemony

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 Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0667
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE 1.745 g  in 29.6 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:0869-0667-38 296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/15/1989
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 07/15/1989
Labeler - Vi Jon, Inc (790752542)
Registrant - Vi Jon, Inc (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi Jon Inc 790752542 manufacture(0869-0667)

Revised: 5/2019
Document Id: 72360fb7-cf9a-4f05-8cc2-014dd9013149
Set id: 83d52e05-7c2b-4811-915e-7ce359282a3b
Version: 3
Effective Time: 20190506
 
Vi Jon, Inc