CITROMA- magnesium citrate liquid

citroma by

Drug Labeling and Warnings

citroma by is a Otc medication manufactured, distributed, or labeled by OLD EAST MAIN CO, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(in each fl oz)

Magnesium citrate 1.745g 

Purpose

Saline laxative

Uses

• 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 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 help professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away

STORAGE AND HANDLING

Store at temperatures between 46° and 86°F (8° and 30° C)

Directions

• shake well before using
• 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 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 in 24 hours

children under 2 years of age - ask a doctor

Other information

• each fl oz contains:magnesium 290 mg
• each fl oz contains:sodium 1 mg

Inactive ingredients

benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water

SPL UNCLASSIFIED SECTION

Non-USP: Non-Carbonated, Non-Pasteurized; Contains Preservatives

Since 1903 Rexall us a registered trademark of Rexall Sundown, Inc.

Visit us at Rexall.com or call 1-866-4-REXALL

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Principal display panel

Since 1903

Rexall

Magnesium

Citrate

Saline Laxative

• Oral Solution
• Relief of occasion constipation

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

Lemon Flavored

10 FL OZ (296 mL)

INGREDIENTS AND APPEARANCE

CITROMA 
magnesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-183
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
BENZOIC ACID (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-183-38	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	09/04/2019

Labeler - OLD EAST MAIN CO (068331990)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(55910-183)