OTC Medication Information: Citroma

CITROMA- magnesium citrate liquid
Select Brand Distributors

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

  • 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 ar e taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how othr 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

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

discard unused product within 24 hours of opening bottle

other information

  • magnesium content 290 mg per 1 fl oz (30 mL)
  • sodium content 80 mg per 1 fl oz (30 mL)
  • store at temperatures between 46º and 86º F (8º and 30º C)

Inactive ingredients

citric acid, lemon oil, potassium bicarbonate, purified water, sodium saccharin,

Adverse Reaction

Distributed by:

SELECT BRAND DISTRIBUTORS

Pine Bluff, Ar 71603

AC (870) 535-3635

686.001/686AF

principal display panel

select brand

the lower price name brand

NDC 15127-686-38

LEMON flavor

MAGNESIUM CITRATE

Very Low Sodium

  • Saline Lazative
  • Oral Solution

Do not use if tamper evident twist-off cap is missing, broken,or separated from neckring

10 FL OZ (296 mL)

image description
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CITROMA
magesium citrate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-686
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
POTASSIUM BICARBONATE
water
SACCHARIN SODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15127-686-38 296 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 03/10/2011
Labeler — Select Brand Distributors (012578514)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (15127-686)

Revised: 05/2021 Select Brand Distributors

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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