Label: CITROMA- magesium citrate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0869-0525-38 - Packager: Vi-Jon
- 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 September 28, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- WARNINGS
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children.
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Directions
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
- Inactive ingredients
- principal display panel
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INGREDIENTS AND APPEARANCE
CITROMA
magesium citrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0525 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0869-0525-38 296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 08/29/1995 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 08/29/1995 Labeler - Vi-Jon (790752542) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 790752542 manufacture(0869-0525)