Label: ANTI-DIARRHEAL- loperamide hcl tablet
- NDC Code(s): 37835-131-01, 37835-131-12, 37835-131-24
- Packager: BI-MART
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 1, 2025
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 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 liquids 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
(34-47 lbs)
ask a doctor children under 2 years (up to 33 lbs) do not use - Other information
- Inactive ingredients
- Questions?
-
Principal Display Panel-12 Caplets
NDC 37835-131-12
Compare to active ingredient in Imodium ®A-D †
ANTI-DIARRHEAL
CAPLETS*
Loperamide HCl Tablets, 2 mg
ANTI-DIARRHEAL
Controls the symptoms of diarrhea
Original Prescription Strength
12 Caplets*
Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg)
†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ®A-D.
Distributed by BI-MART, Eugene, OR 97402
-
Principal Display Panel-24 Caplets
NDC 37835-131-24
Compare to active ingredient in Imodium ®A-D †
ANTI-DIARRHEAL
CAPLETS*
Loperamide HCl Tablets, 2 mg
ANTI-DIARRHEAL
Controls the symptoms of diarrhea
Original Prescription Strength
24 Caplets*
Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg)
†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ®A-D.
Distributed by BI-MART, Eugene, OR 97402
-
Principal Display Panel-100 Caplets
NDC 37835-131-01
Compare to active ingredient in Imodium ®A-D †
ANTI-DIARRHEAL
CAPLETS*
Loperamide HCl Tablets, 2 mg
ANTI-DIARRHEAL
Controls the symptoms of diarrhea
Original Prescription Strength
100 Caplets*
Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg)
†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ®A-D.
Distributed by BI-MART, Eugene, OR 97402
-
INGREDIENTS AND APPEARANCE
ANTI-DIARRHEAL
loperamide hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37835-131 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) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color green (light) Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 44;375 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37835-131-12 2 in 1 CARTON 05/01/2025 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:37835-131-24 4 in 1 CARTON 05/01/2025 2 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:37835-131-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076497 05/01/2025 Labeler - BI-MART (027630078) Registrant - BI-MART (027630078) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 manufacture(37835-131)