OTC Medication Information: Citroma

CITROMA- magnesium citrate liquid
DZA Brads, 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

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
  • abdorominal 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 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

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 Reaction

Distributed by: DZA Brands, LLC

2110 Executive Drive, Salisbury, NC 28147

for product questions or concerns contact us at

1-866-322-2439. Please include UPC number and code from package

principal display panel

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

HEALTY

ACCENTS

magnesium

cirate

saline laxative

oral solution

lemon flavor

pasteurized

sparkling laxative

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:55316-667
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
CITRIC ACID MONOHYDRATE
LEMON OIL
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
SODIUM BICARBONATE
SACCHARIN SODIUM
SUCROSE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55316-667-38 296 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 10/22/2007
Labeler — DZA Brads, LLC (090322194)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (55316-667)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (55316-667)

Revised: 03/2022 DZA Brads, 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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