OTC Medication Information: Citroma

CITROMA- magnesium citrate liquid
C.D.M.A., 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.

Active Ingredient (in each fl oz)

Magnesium citrate 1.745g

Purpose

Saline laxative

Uses

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 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 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

Store at temperatures between 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 maximum 3 fl oz in 24 hours

children under 2 years of age — ask a doctor

other information

  • each fl oz contains: magnesium 290 mg
  • each fl oz contains: sodium 1 mg

Inactive ingredients

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

Non-USP: Non-Carbonated, Non-Pasteurized; Contains Preservatives

Distributed by C.D.M.A., Inc

43157 W 9 Mile Rd

Novi, Mi 48675

www.qualitychoice.com

Questions 800-935-2362

100% QC SATIFCATION GUARANTEED

Principal display panel

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

QC

QUALITY CHOICE

Magnesium

Citrate

Saline Laxative

For the Relief of Occasional Constipation

Lemon Flavor

10 FL OZ (296 mL)

image description
(click image for full-size original)
CITROMA
magnesium citrate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-929
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:63868-929-38 296 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 02/18/2020
Labeler — C.D.M.A., Inc (011920774)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (63868-929)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (63868-929)

Revised: 03/2023 C.D.M.A., Inc

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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