Label: CITROMA- magnesium citrate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-8162-38 - Packager: Walgreen 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 May 18, 2018
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
- 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
- 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 in 24 hours maximum 3 fl oz in 24 hours
children under 2 years of age - ask a doctor
- other information
- Inactive ingredients
- Adverse Reaction
- principal display panel
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INGREDIENTS AND APPEARANCE
CITROMA
magnesium citrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-8162 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:0363-8162-38 296 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 - Walgreen Co (008965063) Registrant - Vi-Jon, Inc (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, Inc 790752542 manufacture(0363-8162)