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Anti-Diarrheal
Loperamide HCl · Tablet
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Bismuth Subsalicylate | 262 mg/1 | 308762 | — |
| Loperamide Hydrochloride | 2 mg/1 | 978006 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Opioid Agonist [EPC] | EPC | All 109 members |
| Opioid Agonists [MoA] | MoA | All 35 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 076497-001 | LOPERAMIDE HYDROCHLORIDE | TABLET | LOPERAMIDE HYDROCHLORIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 7 | Labeling | Approved | April 2, 2021 | Standard |
| Supplement | 2 | Labeling | Approved | September 9, 2015 | — |
| Original application | 1 | Approved | June 10, 2003 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241229). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses relieves: indigestion nausea heartburn diarrhea upset stomach associated with these symptoms
Purpose
openFDA Drug LabelingPurpose Upset stomach reliever and anti-diarrheal
Dosage and Administration
openFDA Drug LabelingDirections 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 hour 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 (up to 33 lbs) do not use
Warnings
openFDA Drug LabelingWarnings Reye's syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products Do not use if you have bloody or black stool an ulcer a bleeding problem Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis When using this product a temporary, but harmless darkening of the stool and/or tongue may occur. Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Do Not Use
openFDA Drug LabelingDo not use if you have bloody or black stool an ulcer a bleeding problem
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have ■ fever ■ mucus in the stool ■ a history of liver disease ■ a history of abnormal heart rhythm
Stop Use
openFDA Drug LabelingStop use and ask a doctor if ■ symptoms get worse ■ diarrhea lasts for more than 2 days ■ you get abdominal swelling or bulging. These may be signs of a serious condition.
Active Ingredient
openFDA Drug LabelingActive ingredient (in each caplet) Bismuth subsalicylate 262 mg
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: LOPERAMIDE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 80513-375-08 | 80513-375 | Advanced Rx LLC | 4 BLISTER PACK in 1 CARTON (80513-375-08) / 6 TABLET in 1 BLISTER PACK | January 3, 2025 |
| 80513-401-24 | 80513-401 | Advanced Rx LLC | 4 BLISTER PACK in 1 CARTON (80513-401-24) / 6 TABLET in 1 BLISTER PACK | August 11, 2024 |
| 37835-131-01 | 37835-131 | BI-MART | 100 TABLET in 1 BOTTLE (37835-131-01) | May 1, 2025 |
| 37835-131-12 | 37835-131 | BI-MART | 2 BLISTER PACK in 1 CARTON (37835-131-12) / 6 TABLET in 1 BLISTER PACK | May 1, 2025 |
| 37835-131-24 | 37835-131 | BI-MART | 4 BLISTER PACK in 1 CARTON (37835-131-24) / 6 TABLET in 1 BLISTER PACK | May 1, 2025 |
| 21130-375-08 | 21130-375 | Better Living Brands, LLC | 4 BLISTER PACK in 1 CARTON (21130-375-08) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 68016-301-18 | 68016-301 | Chain Drug Consortium | 3 BLISTER PACK in 1 CARTON (68016-301-18) / 6 TABLET in 1 BLISTER PACK | December 6, 2019 |
| 68016-301-24 | 68016-301 | Chain Drug Consortium | 4 BLISTER PACK in 1 CARTON (68016-301-24) / 6 TABLET in 1 BLISTER PACK | December 6, 2019 |
| 55910-375-02 | 55910-375 | DOLGENCORP, LLC | 2 BLISTER PACK in 1 CARTON (55910-375-02) / 6 TABLET in 1 BLISTER PACK | January 12, 2024 |
| 55910-375-08 | 55910-375 | DOLGENCORP, LLC | 4 BLISTER PACK in 1 CARTON (55910-375-08) / 6 TABLET in 1 BLISTER PACK | January 12, 2024 |
| 53943-375-02 | 53943-375 | Discount Drug Mart | 2 BLISTER PACK in 1 CARTON (53943-375-02) / 6 TABLET in 1 BLISTER PACK | December 13, 2019 |
| 53943-375-08 | 53943-375 | Discount Drug Mart | 4 BLISTER PACK in 1 CARTON (53943-375-08) / 6 TABLET in 1 BLISTER PACK | December 13, 2019 |
| 55319-375-08 | 55319-375 | Family Dollar Services Inc | 4 BLISTER PACK in 1 CARTON (55319-375-08) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 55319-375-12 | 55319-375 | Family Dollar Services Inc | 2 BLISTER PACK in 1 CARTON (55319-375-12) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 57896-381-13 | 57896-381 | Geri-Care Pharmaceutical Corp | 2 BLISTER PACK in 1 CARTON (57896-381-13) / 6 TABLET in 1 BLISTER PACK | March 1, 2021 |
| 57896-381-25 | 57896-381 | Geri-Care Pharmaceutical Corp | 4 BLISTER PACK in 1 CARTON (57896-381-25) / 6 TABLET in 1 BLISTER PACK | September 1, 2020 |
| 37808-375-08 | 37808-375 | H E B | 4 BLISTER PACK in 1 CARTON (37808-375-08) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 80136-063-11 | 80136-063 | Heartland Pharma Co. | 4 BLISTER PACK in 1 CARTON (80136-063-11) / 6 TABLET in 1 BLISTER PACK | January 22, 2021 |
| 84441-711-02 | 84441-711 | IMO-GEN LABS LLC | 200 TABLET in 1 BOTTLE (84441-711-02) | January 1, 2024 |
| 84441-711-25 | 84441-711 | IMO-GEN LABS LLC | 250 TABLET in 1 BOTTLE (84441-711-25) | February 4, 2026 |
| 84441-711-96 | 84441-711 | IMO-GEN LABS LLC | 96 TABLET in 1 BOTTLE (84441-711-96) | January 1, 2024 |
| 30142-775-02 | 30142-775 | Kroger Company | 2 BLISTER PACK in 1 CARTON (30142-775-02) / 6 TABLET in 1 BLISTER PACK | May 6, 2020 |
| 30142-775-08 | 30142-775 | Kroger Company | 4 BLISTER PACK in 1 CARTON (30142-775-08) / 6 TABLET in 1 BLISTER PACK | May 6, 2020 |
| 50844-259-02 | 50844-259 | L.N.K. International, Inc. | 2 BLISTER PACK in 1 CARTON (50844-259-02) / 6 TABLET in 1 BLISTER PACK | July 15, 2019 |
| 50844-375-02 | 50844-375 | L.N.K. International, Inc. | 3 BLISTER PACK in 1 CARTON (50844-375-02) / 4 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 50844-375-08 | 50844-375 | L.N.K. International, Inc. | 4 BLISTER PACK in 1 CARTON (50844-375-08) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 50844-375-45 | 50844-375 | L.N.K. International, Inc. | 1 BLISTER PACK in 1 CARTON (50844-375-45) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 50844-375-95 | 50844-375 | L.N.K. International, Inc. | 2 BLISTER PACK in 1 CARTON (50844-375-95) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 29485-9286-2 | 29485-9286 | Lil' Drug Store Products, Inc. | 25 POUCH in 1 BOX (29485-9286-2) / 1 TABLET in 1 POUCH | July 27, 2016 |
| 29485-9286-3 | 29485-9286 | Lil' Drug Store Products, Inc. | 30 POUCH in 1 BOX (29485-9286-3) / 1 TABLET in 1 POUCH | July 27, 2016 |
| 66715-6841-4 | 66715-6841 | Lil' Drug Store Products, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (66715-6841-4) / 24 TABLET in 1 BOTTLE, PLASTIC | February 21, 2019 |
| 67296-2314-2 | 67296-2314 | Redpharm Drug | 4 BLISTER PACK in 1 CARTON (67296-2314-2) / 6 TABLET in 1 BLISTER PACK | September 1, 2020 |
| 11822-0375-3 | 11822-0375 | Rite Aid Corporation | 2 BLISTER PACK in 1 CARTON (11822-0375-3) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 11822-0375-8 | 11822-0375 | Rite Aid Corporation | 4 BLISTER PACK in 1 CARTON (11822-0375-8) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 66424-725-24 | 66424-725 | SDA Laboratories, Inc. | 4 BLISTER PACK in 1 CARTON (66424-725-24) / 6 TABLET in 1 BLISTER PACK | February 1, 2024 |
| 41163-375-02 | 41163-375 | United Natural Foods, Inc. dba UNFI | 2 BLISTER PACK in 1 CARTON (41163-375-02) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 41163-375-08 | 41163-375 | United Natural Foods, Inc. dba UNFI | 4 BLISTER PACK in 1 CARTON (41163-375-08) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 63941-375-02 | 63941-375 | Valu Merchandisers Company | 2 BLISTER PACK in 1 CARTON (63941-375-02) / 6 TABLET in 1 BLISTER PACK | May 5, 2020 |
| 63941-375-08 | 63941-375 | Valu Merchandisers Company | 4 BLISTER PACK in 1 CARTON (63941-375-08) / 6 TABLET in 1 BLISTER PACK | May 5, 2020 |
| 0363-0375-02 | 0363-0375 | Walgreen Company | 2 BLISTER PACK in 1 CARTON (0363-0375-02) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 0363-0375-08 | 0363-0375 | Walgreen Company | 4 BLISTER PACK in 1 CARTON (0363-0375-08) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 0363-0375-45 | 0363-0375 | Walgreen Company | 1 BLISTER PACK in 1 CARTON (0363-0375-45) / 6 TABLET in 1 BLISTER PACK | May 3, 2005 |
| 67091-335-18 | 67091-335 | WinCo Foods, LLC | 2 BLISTER PACK in 1 CARTON (67091-335-18) / 6 TABLET in 1 BLISTER PACK | February 8, 2019 |
| 80513-375 | 80513-375 | Advanced Rx LLC | — | January 3, 2025 |
| 80513-401 | 80513-401 | Advanced Rx LLC | — | January 1, 2024 |
| 37835-131 | 37835-131 | BI-MART | — | May 1, 2025 |
| 21130-375 | 21130-375 | Better Living Brands, LLC | — | May 3, 2005 |
| 68016-301 | 68016-301 | Chain Drug Consortium | — | December 6, 2019 |
| 55910-375 | 55910-375 | DOLGENCORP, LLC | — | January 12, 2024 |
| 53943-375 | 53943-375 | Discount Drug Mart | — | December 13, 2019 |
| 55319-375 | 55319-375 | Family Dollar Services Inc | — | May 3, 2005 |
| 57896-381 | 57896-381 | Geri-Care Pharmaceutical Corp | — | January 1, 2006 |
| 37808-375 | 37808-375 | H E B | — | May 3, 2005 |
| 80136-063 | 80136-063 | Heartland Pharma Co. | — | January 22, 2021 |
| 84441-711 | 84441-711 | IMO-GEN LABS LLC | — | January 1, 2024 |
| 30142-775 | 30142-775 | Kroger Company | — | May 6, 2020 |
| 50844-259 | 50844-259 | L.N.K. International, Inc. | — | July 15, 2019 |
| 50844-375 | 50844-375 | L.N.K. International, Inc. | — | May 3, 2005 |
| 29485-9286 | 29485-9286 | Lil' Drug Store Products, Inc. | — | July 27, 2016 |
| 66715-6841 | 66715-6841 | Lil' Drug Store Products, Inc. | — | February 21, 2019 |
| 67296-2314 | 67296-2314 | Redpharm Drug | — | January 1, 2006 |
| 11822-0375 | 11822-0375 | Rite Aid Corporation | — | May 3, 2005 |
| 66424-725 | 66424-725 | SDA Laboratories, Inc. | — | February 1, 2024 |
| 41163-375 | 41163-375 | United Natural Foods, Inc. dba UNFI | — | May 3, 2005 |
| 63941-375 | 63941-375 | Valu Merchandisers Company | — | May 5, 2020 |
| 0363-0375 | 0363-0375 | Walgreen Company | — | May 3, 2005 |
| 67091-335 | 67091-335 | WinCo Foods, LLC | — | February 8, 2019 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.