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 st...
each 30 mL contains: sodium 7 mg store at 20°C to 25°C (68°F to 77°F) do not use if outer neck band is broken or missing.
Drug Facts
Loperamide HCl, USP 1 mg
Anti-diarrheal
controls symptoms of diarrhea, including Travelers' Diarrhea
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 useif you have bloody or black stool
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.
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)
| 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 |
anhydrous citric acid, D&C yellow no. 10, FD&C blue no. 1, flavadew coolmint, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, plain caramel powder, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum
call toll-free 1-888-235-2466
Do not use if outer neck band is broken or missing
PEEL OPEN TO READ COMPLETE DIRECTIONS AND WARNINGS BEFORE PURCHASE
*This product is not manufactured or distributed by the owners of Imodium ®A-D.
Code: TN/Drugs/TN00002222/2006
L0001188 R1125 948006945
Distributed by:
BIONPHARMA INC.
Princeton, NJ 08540
MADE IN INDIA
*Compare to the active ingredient in Imodium ®A-D
a+ health TM
Loperamide HCl Oral Solution, USP
1 mg per 7.5 mL
Anti-DiarrhealOral Solution
Controls the symptoms of diarrhea
Mint Flavor
8 fl oz (240 mL)
* Compare to the active ingredient in Imodium ®A-D
a+ health TM
for ages 6 years & up
Loperamide HCl Oral Solution, USP
1 mg per 7.5 mL
Anti-Diarrheal Oral Solution
Controls the symptoms of diarrhea
Mint Flavor
4 fl oz (120 mL)
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1250685 | loperamide HCl 1 MG in 7.5 mL Oral Suspension | PSN | 1 |
| 1250685 | loperamide hydrochloride 0.133 MG/ML Oral Suspension | SCD | 1 |
| 1250685 | loperamide HCl 1 MG per 7.5 ML Oral Solution | SY | 1 |
| 1250685 | loperamide hydrochloride 1 MG per 7.5 ML Oral Suspension | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| LOPERAMIDE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0369452405550 | GTIN-13: 0369452405550 EAN-13: 0369452405550 GTIN-12: 369452405550 UPC-A: 369452405550 GTIN storage (14 digits): 00369452405550 | image001-ch.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 10f838ef-a72b-645d-80f8-e2255205c3b1 | Product name | 6 | 20240805 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69452-405-55 | Loperamide Hydrochloride | 120 mL in 1 BOTTLE | SOLUTION | 120 | 1 | |
| 69452-405-93 | Loperamide Hydrochloride | 240 mL in 1 BOTTLE | SOLUTION | 240 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69452-405 | 69452-405-55, 69452-405-93 |
Every source-derived ingredient row is available through these pages.
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A220100-001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2025-09-19 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A220100-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2025-09-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A220100-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2025-09-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A220100-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2025-09-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A220100-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2025-09-19 | 31067a03dcf5… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220100-001 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION / ORAL | 2025-09-19 | a50c72e98297… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE ORAL | Bionpharma Inc. | 4bd0939e-c172-d962-e063-6394a90a44b5 | 2026-02-27 | Warnings | 69452-405-55 69452-405-93 69452-405 69452040555 69452040593 4bd07c07-575e-1543-e063-6294a90a9b3c 4bd0939e-c172-d962-e063-6394a90a44b5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.