CITROMA- magesium citrate liquid 
Topco Assoc 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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Magnesium Citrate Oral Solution
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 product

Ask A Doctor before use if you have

  • kidney disease
  • a magnesium or potassium-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

DIST. BY TOPCO ASSOC LLC

7711 GROSS POINT RD

SKOKIE, IL 60077

QUESTIONS? 1-888-423-0139

topcare@topco.com

principal display panel

Top Care

CHERRY FLAVOR

Magnesium Citrate Oral Solution

SALINE LAXATIVE

QUALITY GUARANTEED

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

10 FL OZ (296 mL)

image description

CITROMA 
magesium citrate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-693
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)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-693-38296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/09/200408/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/09/200408/16/2022
Labeler - Topco Assoc LLC (006935977)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(36800-693)

Revised: 8/2022
Document Id: 6aa3b6f7-5075-4c50-a6a4-4a5ae5236285
Set id: 8c8ad799-f986-4c6f-be57-1baaa8f13f78
Version: 11
Effective Time: 20220816
 
Topco Assoc LLC