Label: LEADER ANTI DIARRHEAL- loperamide hcl suspension
- NDC Code(s): 70000-0418-1
- Packager: Cardinal Health 110, LLC. dba Leader
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 17, 2021
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- Official Label (Printer Friendly)
- Active ingredient (in each 7.5 mL)
- Purpose
- Use
- Warnings
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Directions
- •
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- •
- find right dose on chart. If possible, use weight to dose; otherwise use age.
- •
- shake well before using
- •
- use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- •
- mL = milliliter
adults and children 12 years and over
30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours
children 9-11 years
(60-95 lbs)
15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours
children 6-8 years (48-59 lbs)
15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours
children 2-5 years (34 to 47 lbs)
ask a doctor
children under 2
years (up to 33 lbs)
do not use
- Other information
- Inactive ingredients
- Questions or comments?
-
Package/Label Principal Display Panel
Anti-Diarrheal
Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL
Anti-Diarrheal
COMPARE TO IMODIUM® A-D active ingredient
Mint Flavor
For Ages 6 Years and Up
Controls the Symptoms of Diarrhea
Anti-Diarrheal Oral Solution
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SEE NEW WARNING AND DIRECTIONS
4 FL OZ (120 mL)
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INGREDIENTS AND APPEARANCE
LEADER ANTI DIARRHEAL
loperamide hcl suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0418 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 1 mg in 7.5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color GREEN (opaque, viscous)) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0418-1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091292 08/13/2018 Labeler - Cardinal Health 110, LLC. dba Leader (063997360)