CITROMA- magnesium citrate liquid

Citroma by

Drug Labeling and Warnings

Citroma by is a Otc medication manufactured, distributed, or labeled by Vi Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

667.001/667AG

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)

INGREDIENTS AND APPEARANCE

CITROMA 
magnesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0667
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Vi Jon, Inc (790752542)

Registrant - Vi Jon, Inc (790752542)

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