CITROMA- magnesium citrate liquid

citroma by

Drug Labeling and Warnings

citroma by is a Otc medication manufactured, distributed, or labeled by C.D.M.A., Inc, Vi-Jon, Inc. 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

Warnings

for this product

Ask A Doctor

before use if you have

• kidney disease
• a magnesium restricted diet
• abdorominal 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

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

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 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 maximum 3 fl oz in 24 hours

children under 2 years of age - ask a doctor

other information

• each fl oz contains: magnesium 295 mg
• each fl oz contains: sodium 1 mg

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

Distributed by C.D.M.A., Inc

43157 W 9 Mile Rd

Novi, Mi 48675

www.qualitychoice.com

Questions 800-935-2362

principal display panel

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

QC

QUALITY

CHOICE

Magnesium

Citrate

Saline Laxative

For the Relief of Occasional Constipation

Alcohol Content

0.0125%

(From Flavoring)

Lemon Flavor

10 FL OZ (296 mL)

INGREDIENTS AND APPEARANCE

CITROMA 
magnesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-929
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: 63868-929-38	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/18/2020

Labeler - C.D.M.A., Inc (011920774)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(63868-929)