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Loperamide Hydrochloride
loperamide HCl · Solution
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Loperamide Hydrochloride | 1 mg/7.5mL | 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 |
|---|---|---|---|---|---|---|---|
| 091292-001 | LOPERAMIDE HYDROCHLORIDE | SOLUTION | LOPERAMIDE HYDROCHLORIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 16 | Labeling | Approved | December 13, 2021 | Standard |
| Supplement | 12 | Labeling | Approved | December 13, 2021 | Standard |
| Supplement | 8 | Labeling | Approved | November 30, 2015 | Standard |
| Supplement | 3 | Labeling | Approved | November 30, 2015 | Standard |
| Original application | 1 | Approved | May 20, 2011 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260630). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse controls symptoms of diarrhea, including Travelers' Diarrhea Read complete directions and warnings before using.
Purpose
openFDA Drug LabelingPurpose 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. shake well before using use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9 years to 11 years (60 lbs to 95 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6 years to 8 years (48 lbs to 59 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours children 2 years to 5 years (34 lbs to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use
Warnings
openFDA Drug LabelingWarnings 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 Do not use if you have bloody or black stool 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. Stop 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. 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 right away. (1-800-222-1222)
Do Not Use
openFDA Drug LabelingDo not use if you have bloody or black stool
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 7.5 mL) Loperamide HCl, USP 1 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 |
|---|---|---|---|---|
| 17856-6836-1 | 17856-6836 | ATLANTIC BIOLOGICALS CORP. | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6836-1) / 7.5 mL in 1 CUP, UNIT-DOSE (17856-6836-3) | April 22, 2024 |
| 17856-6836-2 | 17856-6836 | ATLANTIC BIOLOGICALS CORP. | 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6836-2) / 15 mL in 1 CUP, UNIT-DOSE (17856-6836-4) | April 22, 2024 |
| 72288-048-34 | 72288-048 | Amazon.com Services LLC | 240 mL in 1 BOTTLE (72288-048-34) | July 30, 2026 |
| 69452-405-55 | 69452-405 | Bionpharma Inc. | 120 mL in 1 BOTTLE (69452-405-55) | March 2, 2026 |
| 69452-405-93 | 69452-405 | Bionpharma Inc. | 240 mL in 1 BOTTLE (69452-405-93) | March 3, 2026 |
| 69842-191-26 | 69842-191 | CVS Pharmacy | 120 mL in 1 BOTTLE (69842-191-26) | June 28, 2018 |
| 69842-191-34 | 69842-191 | CVS Pharmacy | 237 mL in 1 BOTTLE (69842-191-34) | June 28, 2018 |
| 55910-155-55 | 55910-155 | DOLGENCORP INC | 120 mL in 1 BOTTLE (55910-155-55) | March 30, 2026 |
| 81033-067-34 | 81033-067 | Kesin Pharma Corporation | 30 CUP, UNIT-DOSE in 1 CARTON (81033-067-34) / 7.5 mL in 1 CUP, UNIT-DOSE (81033-067-07) | June 30, 2026 |
| 81033-067-35 | 81033-067 | Kesin Pharma Corporation | 30 CUP, UNIT-DOSE in 1 CARTON (81033-067-35) / 15 mL in 1 CUP, UNIT-DOSE (81033-067-15) | June 30, 2026 |
| 0904-6836-20 | 0904-6836 | Major Pharmaceuticals | 120 mL in 1 BOTTLE (0904-6836-20) | November 29, 2018 |
| 41250-813-26 | 41250-813 | Meijer Distribution Inc | 120 mL in 1 BOTTLE (41250-813-26) | July 10, 2018 |
| 68094-029-62 | 68094-029 | Precision Dose, Inc. | 3 TRAY in 1 CASE (68094-029-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 7.5 mL in 1 CUP, UNIT-DOSE (68094-029-59) | May 18, 2020 |
| 68094-129-62 | 68094-129 | Precision Dose, Inc. | 3 TRAY in 1 CASE (68094-129-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (68094-129-59) | May 18, 2020 |
| 68788-7842-1 | 68788-7842 | Preferred Pharmaceuticals Inc. | 120 mL in 1 BOTTLE (68788-7842-1) | January 19, 2021 |
| 11822-5519-2 | 11822-5519 | Rite Aid Corporation | 240 mL in 1 BOTTLE (11822-5519-2) | June 18, 2018 |
| 17856-6836 | 17856-6836 | ATLANTIC BIOLOGICALS CORP. | — | November 29, 2018 |
| 72288-048 | 72288-048 | Amazon.com Services LLC | — | July 30, 2026 |
| 69452-405 | 69452-405 | BIONPHARMA INC. | — | February 27, 2026 |
| 69842-191 | 69842-191 | CVS Pharmacy | — | June 28, 2018 |
| 55910-155 | 55910-155 | DOLGENCORP INC | — | March 30, 2026 |
| 81033-067 | 81033-067 | Kesin Pharma Corporation | — | November 13, 2024 |
| 0904-6836 | 0904-6836 | Major Pharmaceuticals | — | November 29, 2018 |
| 41250-813 | 41250-813 | Meijer Distribution Inc | — | July 10, 2018 |
| 68094-029 | 68094-029 | Precision Dose, Inc. | — | May 18, 2020 |
| 68094-129 | 68094-129 | Precision Dose, Inc. | — | May 18, 2020 |
| 68788-7842 | 68788-7842 | Preferred Pharmaceuticals Inc. | — | January 19, 2021 |
| 11822-5519 | 11822-5519 | Rite Aid Corporation | — | June 18, 2018 |
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.