Label: ANTI DIARRHEAL- loperamide hydrochloride tablet, film coated
-
NDC Code(s):
59779-700-08,
59779-700-53,
59779-700-62,
59779-700-67, view more59779-700-68, 59779-700-72, 59779-700-80, 59779-700-82, 59779-700-89, 59779-700-91
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 13, 2023
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
- Uses
-
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
Ask a doctor before use if you have
- •
- fever
- •
- mucus in the stool
- •
- a history of liver disease
- •
- a history of abnormal heart rhythm
Ask a doctor or pharmacist before use if you are
taking a prescription drug. Loperamide may interact with certain prescription drugs.
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:59779-700 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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:59779-700-53 12 in 1 CARTON 05/12/2003 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:59779-700-89 18 in 1 CARTON 08/21/2007 05/01/2013 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:59779-700-68 36 in 1 CARTON 03/06/2012 09/06/2013 3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:59779-700-67 1 in 1 CARTON 02/24/2003 01/31/2022 4 48 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:59779-700-72 1 in 1 CARTON 02/21/2012 08/05/2016 5 60 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:59779-700-08 1 in 1 CARTON 02/21/2012 06/14/2014 6 108 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:59779-700-80 1 in 1 CARTON 05/24/2004 08/31/2021 7 96 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:59779-700-82 1 in 1 CARTON 06/18/2013 12/31/2021 8 200 in 1 BOTTLE; Type 0: Not a Combination Product 9 NDC:59779-700-91 6 in 1 CARTON 04/07/2003 11/26/2008 9 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 10 NDC:59779-700-62 12 in 1 CARTON 11/08/2022 10 2 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 ANDA075232 02/24/2003 Labeler - CVS Pharmacy (062312574)