Label: ONELAX SALINE LAXATIVE- magnesium citrate liquid
- NDC Code(s): 71399-0051-3
- Packager: AKRON PHARMA INC
- 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 August 14, 2023
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- Official Label (Printer Friendly)
- Active ingredient (30ml (approx. 1 Fl. oz))
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- kidney disease
- a magnesium restricted diet
- a sodium restricted diet
- stomach pain, nausea or vomiting
- noticed a sudden change in bowel habits that lasts more than 1 week
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ONELAX SALINE LAXATIVE
magnesium citrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-0051 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBIC ACID (UNII: X045WJ989B) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71399-0051-3 296 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/04/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 08/04/2023 Labeler - AKRON PHARMA INC (067878881)