CITROMA- magnesium citrate liquid
Vi Jon, 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.

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Swan 667

Active ingredient

Magnesium citrate

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
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

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 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

store at temperatures between 46⁰ and 86⁰F (8⁰ and 30⁰ C)

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 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: sodium 45 mg

Inactive ingredients

citric acid, lemon oil, polyethylene glycol, purified water, sodium bicarbonate, sodium saccharin, sucrose

Adverse reactions section

Distributed by:

Vi-Jon

One Swan Drive

Smyrna, TN 37167

principal display panel

NDC 0869-0667-38

SWAN

Citroma

MAGNESIUM CITRATE

lemony

Oral Solution
Saline Laxative
Pasturized
The sparkling Laxative

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

10 FL OZ (296 mL)

image description

CITROMA
magnesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0869-0667
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)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
water (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0869-0667-38	296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	07/15/1989	08/16/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	07/15/1989	08/16/2022

Labeler - Vi Jon, LLC (790752542)

Registrant - Vi Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		790752542	manufacture(0869-0667)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		088520668	manufacture(0869-0667)

Revised: 8/2022

Document Id: 6f7cc5fe-9c42-4f8d-acca-635b1be02a06

Set id: 83d52e05-7c2b-4811-915e-7ce359282a3b

Version: 12

Effective Time: 20220816

Vi Jon, LLC