Label: ANTI DIARRHEAL- loperamide hydrochloride tablet, film coated
- NDC Code(s): 68788-8951-1, 68788-8951-2, 68788-8951-3, 68788-8951-6
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-7725
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 25, 2024
If you are a healthcare professional or from the pharmaceutical industry 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 reaction 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; 1/2 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; 1/2 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 or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
ANTI DIARRHEAL
loperamide hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-8951(NDC:0904-7725) 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CARNAUBA WAX (UNII: R12CBM0EIZ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color GREEN Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code L2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-8951-1 15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/20/2015 2 NDC:68788-8951-2 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/20/2015 3 NDC:68788-8951-3 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/20/2015 4 NDC:68788-8951-6 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/20/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075232 11/20/2015 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-8951)