CITROMA- magnesium citrate liquid

Citroma by

Drug Labeling and Warnings

Citroma by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy 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

Warnings

Ask a doctor before use if you have

• kidney disease
• a magnesium-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 3 mg per 1 fl oz (30 mL)
• potassium content 84 mg per 1 fl oz (30 mL)
• store at temperatures between 46º and 86º F (8º and 30º C)

Inactive ingredients

 citric acid, flavor, potassium bicarbonate, sodium saccharin, water

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc

One CVS Drive, Woonsoclet, RI 02895

CVS.com  1-800-SHOP CVS

Principal display panel

CVS Health

Dye Free

Magnesium Citrate ORAL SOLUTION

Pasteurized sparkling saline laxative

Cherry Flavor

Alcohol content 0.0031% (from flavoring)

10 FL OZ (296 mL)

380.000/380AA

INGREDIENTS AND APPEARANCE

CITROMA 
magnesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-380
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)
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-380-38	296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/23/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/23/2011

Labeler - CVS Pharmacy Inc (062312574)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(69842-380)