CITROMA- magesium 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 Magnesium Citrate
693

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 products

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

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

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 maximum 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 of 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

  • magnesium content 290 mg per 1 fl oz (30 mL)
  • potassum content 80 mg per 1 fl oz (30 mL)
  • store at temperatures between 46º and 86º F (8º and 30º C)

Inactive ingredients

cherry flavor, citric acid, potassium bicarbonate, purified water, red 40, sodium saccharin

DISTRIBUTED BY:

Vi-Jon

One Swan Drive

Smyrna, TN 37167

Made in the USS

with US and foreign parts

principal display panel

NDC 0869-0693-38

swan

VERY LOW SODIUM

Citroma

MAGNESIUM CITRATE

cherry

  • Saline Laxative
  • Oral Solution
  • Alcohol Content 0.0031% (from flavoring)

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

10 FL OZ (296 mL)

image description

principal display panel

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

mountain falls

low sodium

cherry flavor

magnesium citrate

saline laxative

oral solution

Alcohol content 0.0031% ( from flavoring)

10 FL OZ (296 mL)

image description

CITROMA 
magesium citrate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0693
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
CHERRY (UNII: BUC5I9595W)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
water (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0869-0693-38296 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(0869-0693)

Revised: 8/2022
Document Id: 50870104-312f-49ff-98b6-5523fd19d39a
Set id: 7a43b01e-6217-424f-8990-740d0f026d7b
Version: 12
Effective Time: 20220816
 
Vi-Jon, LLC