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)

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