Magnesium Citrate Liquid [Nucare Pharmaceuticals,inc.] -

MAGNESIUM CITRATE LIQUID [NUCARE PHARMACEUTICALS,INC.]
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NDC	68071-4128-1
Set ID	5c664215-758d-a7a8-e053-2a91aa0a570e
Category	HUMAN OTC DRUG LABEL
Packager	NuCare Pharmaceuticals,Inc.
Generic Name
Product Class
Product Number
Application Number	PART334

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ACTIVE INGREDIENT

Active ingredient
Magnesium citrate 1.745 g per fl oz

Purpose
Saline laxative
INDICATIONS & USAGE

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 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 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.
DOSAGE & ADMINISTRATION

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 25 hours
children 2 to 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 SAFETY INFORMATION

Other information
•magnesium content 290 mg per 1 fl oz (30 mL)
•potassium content 80 mg per 1 fl oz (30 mL)
•store at temperaturs between 46⁰ and 86⁰ F (8⁰ and 30⁰ C)
INACTIVE INGREDIENT

Inactive ingredients cherry flavor, citric acid, FD+C red # 40, potassium bicarbonate, sodium saccharin, water purified
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAGNESIUM CITRATE
magnesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68071-4128(NDC:49348-504)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CITRATE	1.745 g in 29.6 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68071-4128-1	0.296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	10/25/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/01/2002

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Name	Address	ID/FEI	Business Operations
Establishment
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-4128)

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Medic

MAGNESIUM CITRATE LIQUID [NUCARE PHARMACEUTICALS,INC.]

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