Label: CITROMA- magnesium citrate liquid
- NDC Code(s): 62011-0381-1
- Packager: STRATEGIC SOURCING SERVICES LLC
- 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 21, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- use
- Warnings
- Ask A Doctor
- Ask a doctor or pharmacist
- Stop use
- if pregnant or breast-feeding
- Keep out of reach of children.
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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 imaximum 10 fl oz in 24 hours
children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz maximum 3 fl oz in 24 hours
children 2 to under 6 years of age - 2 to 3 fl oz maximum3 fl oz in 24 hours
children under 2 years of age - ask a doctor
- other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
-
principal display panel
Health Mart
NDC 62011-0381-1
Magnesium Citrate Saline Laxative and Oral Solution
Saccharin free
Break resistant
Very low sodium
BPA free
Non-pasteurized
CHERRY FLAVORED
Alcohol content 0.0205% (from flavoring)
DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING
10 FL OZ (296 mL)
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INGREDIENTS AND APPEARANCE
CITROMA
magnesium citrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0381 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:62011-0381-1 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/18/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 02/18/2018 Labeler - STRATEGIC SOURCING SERVICES LLC (116956644) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(62011-0381) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(62011-0381)