Label: SALINE LAXATIVE- magnesium citrate liquid
- NDC Code(s): 0904-6787-44
- Packager: Major Pharmaceuticals
- 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 6, 2022
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- 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 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
- Questions or comments?
- principal display panel
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INGREDIENTS AND APPEARANCE
SALINE LAXATIVE
magnesium citrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6787 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:0904-6787-44 296 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 - Major Pharmaceuticals (191427277) Registrant - Vi-Jon, Inc (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, Inc 790752542 manufacture(0904-6787) Establishment Name Address ID/FEI Business Operations Vi-Jon, Inc 088520668 manufacture(0904-6787)