CITROMA- magnesium citrate liquid

Citroma by

Drug Labeling and Warnings

Citroma by is a Otc medication manufactured, distributed, or labeled by Geiss, Destin & Dunn, Inc., Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Magnesium citrate 1.745 g per fl oz

Purpose

Saline Laxative

Use

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

Warnings

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 use a laxative for a period longer than 1 week

Ask a doctor or pharmacist

before use if you are taking any other drugs. 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 moverment 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.

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 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: sodium 45 mg

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

Distributed By: Geiss, Destin & Dunn, Inc.

385 Highway 74 South

Peachtree City, Ga 30269

www.valuelabels.com

667.001/AG

Principal Display Panel

NDC: 50804-667-38

Good Sense

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

Magnesium Citrate Oral solution

Saline Laxative

• Pasteurized
• Sparkling Laxative

Pleasing Lemony Flavor

100% SATISFACTION GUARANTEED

10 FL OZ (296 mL)

INGREDIENTS AND APPEARANCE

CITROMA 
magnesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-667
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 29.61 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: 50804-667-38	296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	05/18/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/18/2009

Labeler - Geiss, Destin & Dunn, Inc. (076059836)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(50804-667)