Label: LEADER SALINE LAXATIVE - CHERRY- magnesium citrate liquid
- NDC Code(s): 70000-0619-1
- Packager: CARDINAL HEALTH
- 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.
Updated February 27, 2023
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- Active ingredients ( in each fl. oz.)
Ask a docotor before use if you have
- kidney disease
- a magnesium restricted diet
- a potassium restricted diet
- stomach pain, nausea, or vomiting
- noticed a sudden change in bowel habits that persists over a period of 2 weeks
- already used a laxative for a period longer than 1 week
Ask a doctor or pharmacist before use if you are
- taking any other drug.
- Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drug work.
Stop using and ask a doctor if
you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.
- shake well before use
- drink a full glass (8 ounces) of liquid with each dose
- may be taken as a single daily dose or 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 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., maximum 3 fl. oz. in 24 hours children under 2 years of age ask a doctor
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
LEADER SALINE LAXATIVE - CHERRY
magnesium citrate liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0619 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 POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SUCRALOSE (UNII: 96K6UQ3ZD4) BENZOIC ACID (UNII: 8SKN0B0MIM) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) Product Characteristics Color Score Shape Size Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0619-1 296 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 02/01/2023 Labeler - CARDINAL HEALTH (063997360)