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anti diarrheal anti gas
loperamide hydrochloride, simethicone · Tablet
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 |
|---|---|---|---|---|---|---|---|
| 209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | TABLET | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 9 | Labeling | Approved | July 9, 2021 | Standard |
| Supplement | 4 | Labeling | Approved | December 3, 2019 | Standard |
| Original application | 1 | Approved | September 5, 2018 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260904). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses 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 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 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
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 • 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 caplet 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 • 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 caplet
Active Ingredient
openFDA Drug LabelingActive ingredients (in each caplet) Loperamide HCl 2 mg Simethicone 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 |
|---|---|---|---|---|
| 37808-714-53 | 37808-714 | H E B | 12 BLISTER PACK in 1 CARTON (37808-714-53) / 1 TABLET in 1 BLISTER PACK | November 15, 2018 |
| 37808-714-62 | 37808-714 | H E B | 24 BLISTER PACK in 1 CARTON (37808-714-62) / 1 TABLET in 1 BLISTER PACK | February 3, 2020 |
| 42507-699-53 | 42507-699 | HyVee Inc | 12 BLISTER PACK in 1 CARTON (42507-699-53) / 1 TABLET in 1 BLISTER PACK | February 25, 2026 |
| 42507-699-62 | 42507-699 | HyVee Inc | 24 BLISTER PACK in 1 CARTON (42507-699-62) / 1 TABLET in 1 BLISTER PACK | February 25, 2026 |
| 30142-581-53 | 30142-581 | Kroger Company | 12 BLISTER PACK in 1 CARTON (30142-581-53) / 1 TABLET in 1 BLISTER PACK | April 24, 2019 |
| 30142-581-62 | 30142-581 | Kroger Company | 24 BLISTER PACK in 1 CARTON (30142-581-62) / 1 TABLET in 1 BLISTER PACK | February 7, 2020 |
| 11822-1003-2 | 11822-1003 | Rite Aid Corporation | 12 BLISTER PACK in 1 CARTON (11822-1003-2) / 1 TABLET in 1 BLISTER PACK | January 3, 2019 |
| 11822-1003-3 | 11822-1003 | Rite Aid Corporation | 24 BLISTER PACK in 1 CARTON (11822-1003-3) / 1 TABLET in 1 BLISTER PACK | February 24, 2020 |
| 37808-714 | 37808-714 | H E B | — | November 15, 2018 |
| 42507-699 | 42507-699 | HyVee Inc | — | February 25, 2026 |
| 30142-581 | 30142-581 | Kroger Company | — | April 24, 2019 |
| 11822-1003 | 11822-1003 | Rite Aid Corporation | — | January 3, 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 · 10 sections on this page.