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anti diarrheal
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 20250411). 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
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 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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
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 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 |
|---|---|---|---|---|
| 37808-449-34 | 37808-449 | H E B | 240 mL in 1 BOTTLE (37808-449-34) | June 22, 2018 |
| 30142-514-34 | 30142-514 | Kroger Company | 236 mL in 1 BOTTLE (30142-514-34) | June 11, 2018 |
| 0363-2022-26 | 0363-2022 | Walgreen Company | 120 mL in 1 BOTTLE (0363-2022-26) | March 21, 2022 |
| 0363-2022-34 | 0363-2022 | Walgreen Company | 240 mL in 1 BOTTLE (0363-2022-34) | March 21, 2022 |
| 37808-449 | 37808-449 | H E B | — | June 22, 2018 |
| 30142-514 | 30142-514 | Kroger Company | — | June 11, 2018 |
| 0363-2022 | 0363-2022 | Walgreen Company | — | March 21, 2022 |
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.