Your browser does not support JavaScript! MAGNESIUM CITRATE (MAGNESIUM CITRATE) LIQUID [KINRAY INC]
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MAGNESIUM CITRATE (magnesium citrate) liquid
[Kinray Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient

Magnesium Citrate 1.745g per fl oz

Purpose

saline laxative

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 1/2 to 6 hours

Warnings

ask a doctor before use if you have

kidney disease
a magnesium restricted diet

a sodium restricted diet
stomach pain,  nausea or vomiting
noticed a sudden change in bowel habits that lasts more than one week


Ask a doctor or pharmacist before use if you are

presently taking a prescription drug

when using this product

do not exceed the maximum recommended daily dosage in a 24 hour period

Stop use and ask a doctor if

you have rectal bleeding or no bowel movement after use .

These could be a sign of a serious condition.

you need to use a laxative more than one week.

If pregnant or breast feeding

ask a health professional before use.

keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Directions

Adults and Children 12 years of age and older             1/2 to 1 bottle (10 fl oz). Drink a full 8 oz glass of liquid with each dose.                                                                                 The dose may be taken as a single daily dose or in divided doses.


children 6 to under 12 years of age                               1/3 to 1/2 bottle with a full 8 oz glass of liquid.


children under 6 years of age                                        consult a doctor


Other Information

each fluid ounce contains: sodium 36 mg

store at controlled room temperature

protect from excessive heat and freezing

discard unused product within 24 hours of opening bottle


Inactive Ingredients

Citric acid, flavors, purified water, saccharin sodium, sodium bicarbonate

Questions?

Adverse Drug Events Call: (800) 616-2471

Principal Display Panel

Preferred Plus Pharmacy

Pasteurized

The Sparkling Laxative

Magnesium

Citrate

Oral Solution

(Citrate of Magnesia)

Lemon Flavor

TAMPER EVIDENT:  DO NOT USE IF THE BREAKAWAY

BAND ON CAP IS BROKEN OR MISSING

10 FL OZ (296 mL)

image of label

MAGNESIUM CITRATE  
magnesium citrate liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63777-314
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM CITRATE (magnesium cation) MAGNESIUM CITRATE2.65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water 
CITRIC ACID MONOHYDRATE 
SACCHARIN SODIUM ANHYDROUS 
SODIUM BICARBONATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (Lemon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63777-314-16296 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/20/2009
Labeler - Kinray Inc (012574513)
Registrant - Aaron Industries, Inc. (030119387)
Establishment
NameAddressID/FEIBusiness Operations
Aaron Industries, Inc.030119387analysis, manufacture

Revised: 11/2009
 
Kinray Inc

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