CITROMA- magesium citrate liquid

citroma by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

Warnings

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 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 movement after use. These could be signs of a serious condition.

If pregnant or breast-feeding

 ask 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 of 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)
• potassum content 80 mg per 1 fl oz (30 mL)
• store at temperatures between 46º and 86º F (8º and 30º C)

Inactive ingredients

cherry flavor, citric acid, FD+C red #40, potassium bicarbonate, sodium saccharin, water purified

SPL UNCLASSIFIED SECTION

DIST. BY TOPCO ASSOC LLC

7711 GROSS POINT RD

SKOKIE, IL 60077

QUESTIONS? 1-888-423-0139

topcare@topco.com

principal display panel

Top Care

CHERRY FLAVOR

Magnesium Citrate Oral Solution

SALINE LAXATIVE

QUALITY GUARANTEED

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

10 FL OZ (296 mL)

693.001/693AE

INGREDIENTS AND APPEARANCE

CITROMA 
magesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-693
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
CHERRY (UNII: BUC5I9595W)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-693-38	296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	07/09/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/09/2004

Labeler - Topco Assoc LLC (006935977)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(36800-693)