CITROMA- magesium citrate liquid

citroma by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient (in each fl oz)

Magnesium citrate 1.745 g

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

• 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

• each fl oz contains: magnesium 290 mg
• each fl oz contains: potassum 80 mg 
• store at temperatures between 46º and 86º F (8º and 30º C)

Inactive ingredients

cherry flavor, citric acid, potassium bicabonate, purified water, red 40, sodium saccharin

Questions or Comments

Call 1-877-932-7948

Adverse Reactions section

Distributed by SUPERVLU INC

Eden Parier, MN 55344 USA

Contact us at 1-877-932-7948

or www.supervalu-ourownbrands.com

693.001/963AE

principal disply\\\

EQUALINE

magnesium citrate

saline laxative

oral solution

sparkling laxative:

• saline laxative
• pasteurized
• cherry flavor

ALCOHOL CONTENT

0.0031% (FROM FLAVORING)

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

10 fl oz (296 mL)

INGREDIENTS AND APPEARANCE

CITROMA 
magesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-693
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)
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-693-38	296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	12/09/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	12/09/2004

Labeler - Supervalu, Inc (006961411)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(41163-693)