Label: CITRATE OF MAGNESIUM liquid
Contains inactivated NDC Code(s)
NDC Code(s): 54868-0010-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0869-0686
- 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.
Drug Label Information
Updated July 6, 2012
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
WarningsAsk a doctor before you 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 your 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.
DOSAGE & ADMINISTRATION
Directions • drink a full glass (8 ounces) of liquid wit 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 - ask a doctor
discard unused product within 24 hours of opening bottle
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- ADVERSE REACTIONS
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
CITRATE OF MAGNESIUM
citrate of magnesium liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-0010(NDC:0869-0686) 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 LEMON OIL (UNII: I9GRO824LL) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-0010-0 .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 01/29/2003 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel(54868-0010)