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Loperamide Hydrochloride and Simethicone
Overview
Active ingredients
Source: NDC DirectoryForms, 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 |
| Skin Barrier Activity [PE] | PE | 5 members — no class page |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 211059-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | TABLET | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | December 14, 2020 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251201). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUSE(S) relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Purpose
openFDA Drug LabelingPURPOSES Anti-diarrheal Anti-gas
Dosage and Administration
openFDA Drug LabelingDirections drink plenty of clear fluids to help prevent dehydration caused by diarrhea take only on an empty stomach (1 hour before or 2 hours after a meal) take with a full (8 oz.) glass of water find right dose on chart below. If possible, use weight to dose; otherwise, use ag 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 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use Other information each caplet contains: calcium 148.40 mg, sodium 1.40 mg store between 20-25°C (68-77°F). Protect from light. for blister: do not use if blister unit is torn or broken
Warnings
openFDA Drug LabelingWARNINGS Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride HEART ALERT Taking more than directed can cause serious heart problems or death. DO NOT USE • if you have bloody or black stool • if you have difficulty swallowing 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. • you have difficulty swallowing the tablet If pregnant or breast-feeding , ask a health professional before use. 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)
HEART ALERT Taking more than directed can cause serious heart problems or death.
Do Not Use
openFDA Drug LabelingDO NOT USE • if you have bloody or black stool • if you have difficulty swallowing
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. • you have difficulty swallowing the tablet If pregnant or breast-feeding , ask a health professional before use.
Active Ingredient
openFDA Drug LabelingACTIVE INGREDIENT(S) (in each tablet) Loperamide Hydrochloride USP 2 mg Simethicone USP 125 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 |
|---|---|---|---|---|
| 59651-149-22 | 59651-149 | Aurobindo Pharma Limited | 2000 TABLET in 1 BAG (59651-149-22) | December 14, 2020 |
| 58602-815-74 | 58602-815 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-815-74) / 6 TABLET in 1 BLISTER PACK | December 14, 2020 |
| 58602-815-75 | 58602-815 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-815-75) / 6 TABLET in 1 BLISTER PACK | December 14, 2020 |
| 58602-815-76 | 58602-815 | Aurohealth LLC | 4 BLISTER PACK in 1 CARTON (58602-815-76) / 6 TABLET in 1 BLISTER PACK | December 14, 2020 |
| 58602-815-80 | 58602-815 | Aurohealth LLC | 3 BLISTER PACK in 1 CARTON (58602-815-80) / 6 TABLET in 1 BLISTER PACK | December 14, 2020 |
| 58602-868-76 | 58602-868 | Aurohealth LLC | 4 BLISTER PACK in 1 CARTON (58602-868-76) / 6 TABLET in 1 BLISTER PACK | February 24, 2021 |
| 58602-869-76 | 58602-869 | Aurohealth LLC | 4 BLISTER PACK in 1 CARTON (58602-869-76) / 6 TABLET in 1 BLISTER PACK | February 24, 2021 |
| 58602-869-80 | 58602-869 | Aurohealth LLC | 3 BLISTER PACK in 1 CARTON (58602-869-80) / 6 TABLET in 1 BLISTER PACK | May 16, 2021 |
| 21130-222-24 | 21130-222 | Better Living Brands, LLC | 4 BLISTER PACK in 1 CARTON (21130-222-24) / 6 TABLET in 1 BLISTER PACK | July 21, 2023 |
| 21130-222-76 | 21130-222 | Better Living Brands, LLC | 3 BLISTER PACK in 1 CARTON (21130-222-76) / 6 TABLET in 1 BLISTER PACK | July 21, 2023 |
| 69452-210-04 | 69452-210 | Bionpharma Inc. | 1 BLISTER PACK in 1 CARTON (69452-210-04) / 6 TABLET in 1 BLISTER PACK | December 19, 2021 |
| 69452-210-12 | 69452-210 | Bionpharma Inc. | 4 BLISTER PACK in 1 CARTON (69452-210-12) / 6 TABLET in 1 BLISTER PACK | December 19, 2021 |
| 69452-531-12 | 69452-531 | Bionpharma Inc. | 4 BLISTER PACK in 1 CARTON (69452-531-12) / 6 TABLET in 1 BLISTER PACK | January 7, 2026 |
| 69230-325-00 | 69230-325 | Camber Consumer Care Inc | 10 POUCH in 1 DRUM (69230-325-00) / 1000 TABLET in 1 POUCH | June 17, 2021 |
| 69230-325-04 | 69230-325 | Camber Consumer Care Inc | 1 BLISTER PACK in 1 CARTON (69230-325-04) / 4 TABLET in 1 BLISTER PACK | June 17, 2021 |
| 69230-325-06 | 69230-325 | Camber Consumer Care Inc | 1 BLISTER PACK in 1 CARTON (69230-325-06) / 6 TABLET in 1 BLISTER PACK | June 17, 2021 |
| 69230-325-08 | 69230-325 | Camber Consumer Care Inc | 2 BLISTER PACK in 1 CARTON (69230-325-08) / 4 TABLET in 1 BLISTER PACK | June 17, 2021 |
| 69230-325-12 | 69230-325 | Camber Consumer Care Inc | 2 BLISTER PACK in 1 CARTON (69230-325-12) / 6 TABLET in 1 BLISTER PACK | June 17, 2021 |
| 69230-325-18 | 69230-325 | Camber Consumer Care Inc | 3 BLISTER PACK in 1 CARTON (69230-325-18) / 6 TABLET in 1 BLISTER PACK | June 17, 2021 |
| 69230-325-24 | 69230-325 | Camber Consumer Care Inc | 4 BLISTER PACK in 1 CARTON (69230-325-24) / 6 TABLET in 1 BLISTER PACK | June 17, 2021 |
| 81522-325-24 | 81522-325 | FSA store INC | 4 BLISTER PACK in 1 CARTON (81522-325-24) / 6 TABLET in 1 BLISTER PACK | June 30, 2024 |
| 55319-052-75 | 55319-052 | Family Dollar Stores, LLC | 2 BLISTER PACK in 1 CARTON (55319-052-75) / 6 TABLET in 1 BLISTER PACK | August 11, 2023 |
| 62207-739-69 | 62207-739 | Granules India Ltd | 2 BLISTER PACK in 1 CARTON (62207-739-69) / 6 TABLET in 1 BLISTER PACK | March 1, 2023 |
| 84441-713-10 | 84441-713 | IMO-GEN LABS LLC | 100 TABLET in 1 BOTTLE (84441-713-10) | October 23, 2025 |
| 80136-384-24 | 80136-384 | NORTHEAST PHARMA | 4 BLISTER PACK in 1 CARTON (80136-384-24) / 6 TABLET in 1 BLISTER PACK | October 27, 2021 |
| 0363-9606-75 | 0363-9606 | WALGREEN CO. | 2 BLISTER PACK in 1 CARTON (0363-9606-75) / 6 TABLET in 1 BLISTER PACK | August 3, 2022 |
| 0363-9606-76 | 0363-9606 | WALGREEN CO. | 4 BLISTER PACK in 1 CARTON (0363-9606-76) / 6 TABLET in 1 BLISTER PACK | August 3, 2022 |
| 79903-223-12 | 79903-223 | WALMART INC. | 2 BLISTER PACK in 1 CARTON (79903-223-12) / 6 TABLET in 1 BLISTER PACK | February 17, 2024 |
| 79903-223-24 | 79903-223 | WALMART INC. | 4 BLISTER PACK in 1 CARTON (79903-223-24) / 6 TABLET in 1 BLISTER PACK | February 17, 2024 |
| 59651-149 | 59651-149 | Aurobindo Pharma Limited | — | December 14, 2020 |
| 58602-815 | 58602-815 | Aurohealth LLC | — | December 14, 2020 |
| 58602-868 | 58602-868 | Aurohealth LLC | — | February 24, 2021 |
| 58602-869 | 58602-869 | Aurohealth LLC | — | February 24, 2021 |
| 21130-222 | 21130-222 | Better Living Brands, LLC | — | July 21, 2023 |
| 69452-210 | 69452-210 | Bionpharma Inc. | — | December 1, 2021 |
| 69452-531 | 69452-531 | Bionpharma Inc. | — | January 7, 2026 |
| 69230-325 | 69230-325 | Camber Consumer Care Inc | — | June 17, 2021 |
| 81522-325 | 81522-325 | FSA store INC | — | June 30, 2024 |
| 55319-052 | 55319-052 | Family Dollar Stores, LLC | — | August 11, 2023 |
| 62207-739 | 62207-739 | Granules India Ltd | — | March 1, 2023 |
| 84441-713 | 84441-713 | IMO-GEN LABS LLC | — | October 23, 2025 |
| 80136-384 | 80136-384 | NORTHEAST PHARMA | — | October 27, 2021 |
| 0363-9606 | 0363-9606 | WALGREEN CO. | — | August 3, 2022 |
| 79903-223 | 79903-223 | WALMART INC. | — | February 17, 2024 |
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 · 10 sections on this page.