MAGNESIUM CITRATE- freskaro magnesium citrate oral solution - grape liquid

Magnesium Citrate by

Drug Labeling and Warnings

Magnesium Citrate by is a Otc medication manufactured, distributed, or labeled by Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Magnesium citrate 1.745g per fl oz

Purpose

Saline Laxtive

Use

for relief of occasional constipation (irregularity).
Generally produces bowel movement in 1/2 to 6 hours

Warnings

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 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.

Other Information

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 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 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 290 mg
each fl oz contains: sodium 1 mg

Inactive Ingredients

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

Questions?

1-833-551-0932

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAGNESIUM CITRATE 
freskaro magnesium citrate oral solution - grape liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82645-311
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)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82645-311-10	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/27/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	12/27/2022

Labeler - Pharma Nobis, LLC (118564114)

Registrant - Pharma Nobis, LLC (118856114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	label(82645-311) , manufacture(82645-311) , analysis(82645-311) , pack(82645-311)