OTC Medication Information: Citroma

CITROMA- magnesium citrate liquid
Harris Teeter, 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 1.745 g per fl oz

Purpose

Saline Laxative

Use

for relief of occasional constipation (irregularity). Generally productes bowel movement in 1/2 to 6 hours.

Warnings

for this product

Ask a doctor before use

If you have

• kidney disease
• a magnesium or potassium-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 durgs. Laxatives may affect how other durgs 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 serious condition.

If pregnant or breast-feeding

Ask a 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 dose or in divided doses

Adults and children 12 years 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

discard unused product within 24 hours of opening bottle

Other information

• each fl oz contains: magnesium 290 mg
• each fl oz contains: potassium 80 mg
• store at temperatures between 46⁰ and 86⁰ F (8⁰ and 30⁰ C)

inactive ingredients

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

Questions?

Call 1-888-593-0593

Adverse reactions

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC, MATTHEWS, NC 28105

your plus guarantee

1-800-432-6111 or harristeeter.com

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Harris Teeter

Magnesium

Citrate

Oral Solution

Saline Laxative

Very Low Sodium

Lemon Flavor

Sugar Free

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

10 FL OZ 296 mL)

CITROMA magesium citrate liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72036-686 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 29.61 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:72036-686-38 296 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 05/03/2017

Labeler — Harris Teeter, LLC (047279351)

Registrant — Vi-Jon, LLC (790752542)

Establishment
Name	Address	ID/FEI	Operations
Vi-Jon, LLC		790752542	manufacture (72036-686)

Establishment
Name	Address	ID/FEI	Operations
Vi-Jon, LLC		088520668	manufacture (72036-686)

Revised: 05/2022 Harris Teeter, LLC