Label: CITROMA- magnesium citrate liquid
- NDC Code(s): 55910-615-38
- Packager: OLD EAST MAIN CO
- 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 March 31, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each fl oz)
- Purpose
- Uses
- 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.
- STORAGE AND HANDLING
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Directions
- shake well before using
- 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 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 in 24 hours
children under 2 years of age - ask a doctor
- other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Principal display panel
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INGREDIENTS AND APPEARANCE
CITROMA
magnesium citrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-615 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 BENZOIC ACID (UNII: 8SKN0B0MIM) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SUCRALOSE (UNII: 96K6UQ3ZD4) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-615-38 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/04/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/04/2019 Labeler - OLD EAST MAIN CO (068331990) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55910-615) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-615)