OTC Medication Information: Citroma

CITROMA- magnesium 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.

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 sodium restricted diet
  • abdorominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits tat 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 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

other informaiton

Store at temperatures betweem 46° and 86°F (8° and 30° 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 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

  • each fl oz contains: magnesium 295 mg
  • each fl oz contains: sodium 1 mg

Inactive ingredients

benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water

Adverse Reaction

DIST. BY TOPCO ASSOC LLC

ELK GROVE VILLAGE, IL 60007 TOPCO VIJA 0818

QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

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TopCare

Health

NDC 36800-164-38

Magnesium

Citrage

OUR PHARMACISTS RECOMMEND

SALINE LAZATIVE

ORAL SOLUTION

Alcohol content 0.025% (from flavoring)

For Relief of Occasional Constipation

CHERRY FLAVOR

TAMPER EVIDENT: DO NOT USE IF THE BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

10 FL OZ (296 mL)

image description
(click image for full-size original)
CITROMA
magesium citrate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-164
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM CITRATE (MAGNESIUM CATION) MAGNESIUM CITRATE 1.745 g in 29.6 mL
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM ANHYDROUS
SUCRALOSE
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-164-38 296 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 02/18/2018
Labeler — TOPCO ASSOC, LLC (006935977)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (36800-164)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (36800-164)

Revised: 03/2022 TOPCO ASSOC, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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