MAGNESIUM CITRATE liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Magnesium citrate (UNII: RHO26O1T9V) (magnesium cation - UNII:T6V3LHY838)
Available from:
Cardinal Health
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours
Authorization status:
OTC monograph not final
Authorization number:
70000-0318-1

MAGNESIUM CITRATE- magnesium citrate liquid

Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Leader 667

Active ingredient

Magnesium citrate 1.745 g per fl oz

Purpos e

Saline Laxative

Us e

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 or sodium-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 a 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.

storage information

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 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

each fl oz contains: magnesium content 290 mg

each fl oz contains: sodium 45 mg

Inactive ingredients

citric acid, lemon oil, polyethylene glycol, purified water, sodium bicarbonate, sodium saccharin,

sucrose

Ques tions ?

Call 1-888-593-0593

Dis claimer

CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are tradmarked

or registered trademark of Cardinal Health

Adverse reaction

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO, 43017

www.myleader.com

1-800-200-6313

Essential to Care since 1979

100% Money Back Guarantee

Return to place of purchase

CardinalHealth

CIN 5385141

REV. 9/17

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

FROM NECKRING

667.001/667AG

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

LEADER

NDC 70000-0318-1

MAGNESIUM

CITRATE

SALINE LAXATIVE

LEMON FLAVOR

ORALSOLUTION

PASTEURIZED SPARKLING

LAXATIVE

DYE-FREE

100% MONEY BACK GUARANTEE

10 FL OZ (296 mL)

MAGNESIUM CITRATE

magnesium citrate liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 318

Cardinal Health

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Ma g nesium citra te (UNII: RHO26 O1T9 V) (magnesium catio n - UNII:T6 V3LHY8 38 )

Magnesium citrate

1.745 g in 29 .6 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

LEMO N O IL (UNII: I9 GRO8 24LL)

PO LYETHYLENE GLYCO L 10 0 0 (UNII: U0 76 Q6 Q6 21)

wa ter (UNII: 0 59 QF0 KO0 R)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SUCRO SE (UNII: C151H8 M554)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

LEMON

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:70 0 0 0 -

0 318 -1

.29 6 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

0 6 /21/19 8 9

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt334

0 6 /21/19 8 9

Labeler -

Cardinal Health (097537435)

Registrant -

Vi-Jon, Inc (790752542)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n, Inc

79 0 752542

ma nufa c ture (70 0 0 0 -0 318 )

Revised: 9/2020

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