Label: MAGNESIUM CITRATE - magnesium citrate liquid
- NDC Code(s): 63777-314-16
- Packager: Kinray Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated November 12, 2009
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- Active ingredient
Magnesium Citrate 1.745g per fl ozClose
relieves occasional constipation (irregularity)
generally produces bowel movement in 1/2 to 6 hoursClose
ask a doctor before use if you have
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 drugClose
- when using this product
do not exceed the maximum recommended daily dosage in a 24 hour periodClose
- 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.Close
- If pregnant or breast feeding
ask a health professional before use.Close
- 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.
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 bicarbonateClose
Adverse Drug Events Call: (800) 616-2471Close
- Principal Display Panel
Preferred Plus Pharmacy
The Sparkling Laxative
(Citrate of Magnesia)
TAMPER EVIDENT: DO NOT USE IF THE BREAKAWAY
BAND ON CAP IS BROKEN OR MISSING
10 FL OZ (296 mL)
- INGREDIENTS AND APPEARANCE
magnesium citrate liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63777-314 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM CITRATE (UNII: RHO26O1T9V) (magnesium cation - UNII:T6V3LHY838) MAGNESIUM CITRATE 2.65 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color Score Shape Size Flavor LEMON (Lemon) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63777-314-16 296 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/20/2009 Labeler - Kinray Inc (012574513) Registrant - Aaron Industries, Inc. (030119387) Establishment Name Address ID/FEI Business Operations Aaron Industries, Inc. 030119387 analysis, manufacture