OTC Medication Information: Citroma

CITROMA- magnesium citrate liquid
MIDWOOD BRANDS, 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 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

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

Directions

  • shake well first
  • 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 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

TEP

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

Adverse Reaction

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

NOT 100% SATISFIED?

Return pckage and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange

principal display panel

FAMILY

Wellness

NDC 55319-164-38

Magnesium

Citrate

Saline laxative

Alcohol content

0.0250% (from flavoring)

CHERRY

100% SATISFACTION GUARANTEED

OR YOUR MONEY BACK

10 FL OZ (295 mL)

image description
(click image for full-size original)
CITROMA
magnesium citrate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-164
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
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55319-164-38 296 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 02/18/2019
Labeler — MIDWOOD BRANDS, LLC (024472631)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (55319-164)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (55319-164)

Revised: 10/2021 MIDWOOD BRANDS, 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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