CITROMA- magesium citrate liquid
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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.

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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 are 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:

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Pine Bluff, Ar 71603

AC (870) 535-3635

686.001/686AF

principal display panel

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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

CITROMA
magesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15127-686
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CITRATE	1.745 g in 29.6 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LEMON OIL (UNII: I9GRO824LL)
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
water (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:15127-686-38	296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/10/2011	05/19/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/10/2011	05/19/2022

Labeler - Select Brand Distributors (012578514)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(15127-686)

Revised: 5/2022

Document Id: 94959a61-d35d-44a3-892d-841c60f82657

Set id: 9c702995-933f-4a70-9d4e-101931d342f7

Version: 23

Effective Time: 20220519

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