Label: ANTI-DIARRHEAL- loperamide hcl tablet, coated
- NDC Code(s): 53117-248-86
- Packager: First Aid Direct
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 19, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each caplet)
- Purpose
- Use
-
Warnings
Allergy alert: Do not use if you have ever had a rash or other allergic reactions to Loperamide HCl.
Heart alert: Taking more than directed can cause serious heart problems or death.
When using this product
tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.
-
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.
- adults and children 12 years and over: 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
- children 9-11 years (60-95 lbs): 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
- children 6-8 years (48-59 lbs): 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets 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
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
ANTI-DIARRHEAL
loperamide hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53117-248 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color green Score 2 pieces Shape CAPSULE Size 10mm Flavor Imprint Code 44;375 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53117-248-86 2 in 1 CARTON 05/03/2005 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076497 05/03/2005 Labeler - First Aid Direct (962283128)
