CITROMA- magesium citrate liquid

citroma by

Drug Labeling and Warnings

citroma by is a Otc medication manufactured, distributed, or labeled by Select Brands distributors, Vi-Jon. 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

Wanings

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 afte 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 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, potassium bicarbonate, purified water, red 40, sodium saccharin

adverse reactions

Distributed by:

SELECT BRAND DISTRIBUTORS

Pine Bluff, AR 71603

AC (870) 535-3635

693.001/693AE

PRINCIPAL DISPLAY PANEL

Select Brand

the lower price name brand

NDC: 15127-693-38

CHERRY Flavor

MAGNESIUM CITRATE

Very Low Sodium

• Saline Laxative
• Oral Solution
• Alcohol Content

0.0031% (from flavoring)

Do not us 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: 15127-693
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: 15127-693-38	296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	10/04/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/04/1993

Labeler - Select Brands distributors (012578514)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(15127-693)