CITROMA- magnesium citrate liquid

Citroma by

Drug Labeling and Warnings

Citroma by is a Otc medication manufactured, distributed, or labeled by UNFI, Vi-Jon, LLC. 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

• magnesium content 290 mg per 1 fl oz (30 mL)
• sodium content 45 mg per 1 fl oz (30 mL)
• store at temperatures between 46º and 86º F (8º and 30º C)

Inactive ingredients

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

Questions or comments

1-877-932-7948

Adverse Reactions

Distributed by SUPERVALU INC

Eden Prairie, MN 55344 USA

Contact us at 1-877-932-7948

or www.supervalu-ourownbrands.com

667.001/667AG

principal display panel

EQUALINE

magnesium

citrate

saline laxative

oral solution

sparkling laxative:

• saline laxative
• pasteurized

lemon flavor

DO NOT USE IF TAMPER EVIDENT TWIST-OF CAP IS MISING, 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: 41163-667
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: 41163-667-38	296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	11/18/2001

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	11/18/2001

Labeler - Supervalue, INC (006961411)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(41163-667)