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Imodium A-D Loperamide Hydrochloride 2 mg Capsule, Liquid Filled

by Kenvue Brands LLC · 2 BLISTER PACK in 1 CARTON (50580-367-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
NDC 50580-0367-02
🏷️ FDA NDC (as labeled) 50580-367-02 billing pads the product segment with a zero
This package
Contains12 capsule, liquid filled in 1 blister pack Pack sizes2 compare ↓
Also comes in: 12 capsules 50580-0367-01
OTC Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 50580-367-02
Product NDC 50580-367
11-digit billing NDC 50580036702
NCPDP billing unit EA — each (per item)
RxCUI 978006, 978009
UNII 77TI35393C
UPC 0300450137241
Application # NDA021855
SPL Set ID 31bfcbb4-c58c-4edc-ac68-356a448b7507
Established class (EPC) Opioid Agonist
Mechanism of action Opioid Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-07-11
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance LOPERAMIDE HYDROCHLORIDE
GPI-14 47100020100105
GCN Seq No 002842
GCN 08370
HICL code 001236
Ingredient (HICL) Loperamide Hcl
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6D
Therapeutic class — specific (HIC3) Antidiarrheals
AHFS code 56:08.00.00
AHFS class Antidiarrhea Agents
FDB label name IMODIUM A-D 2 MG SOFTGEL
FDB brand name Imodium A-D
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 50580-367-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50580-0367-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Antipropulsives
How it works Opioid Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerKenvue Brands LLC
Application holderBIONPHARMA INC
FDA applicationNDA021855 (NDA)
Labeler code50580
First marketedJul 2016
Product typeHuman Otc Drug
Portfolio567 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name IMODIUM A-D 2 MG SOFTGEL Ingredient Loperamide Hcl
📖 What it is MedlinePlus · NLM

Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Lop...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Loperamide works by binding to the same type of receptors in your gut that opioids do, but it stays mostly in the intestines and very little gets into your bloodstream at the recom...
  • What exactly does loperamide do — and is it like taking an opioid?
  • For acute diarrhea, stop and call your doctor if symptoms don't improve within 2 days, or if they get worse. You should also stop right away if you develop bloating or a swollen be...
  • How long can I take loperamide before I should see a doctor?
📖 Read our full Loperamide guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color blue
ShapeOval
ImprintIMO
Size12 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesbutylated hydroxyanisole, edible ink, FD&C blue no. 1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 12 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Loperamide Hydrochloride 2 mg 00093-0311-01 Teva 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 00378-2100-01 Mylan 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 00904-7472-61 Major 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 42799-0605-01 Edenbridge 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 50268-0482-15 AvPAK 50 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 51079-0690-20 Mylan 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 59651-0691-01 Aurobindo 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 60687-0229-01 American 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 69452-0271-20 Bionpharma 100 capsules $0.055 AB Availability likely —
Loperamide hydrochloride 2 mg 72578-0138-01 Viona 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 72603-0328-01 NorthStar 100 capsules $0.055 AB Availability likely —
Anti-Diarrheal 2 mg 46122-0581-62 AMERISOURCE 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 70000-0461-01 CARDINAL 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 70677-1062-01 STRATEGIC 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 83324-0208-12 CHAIN 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 83324-0209-24 CHAIN 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 63868-0876-12 CHAIN 12 capsules $0.140 — FDA listed —
Anti-Diarrheal 2 mg 62011-0390-01 Strategic 12 capsules $0.150 — FDA listed —
Anti-Diarrheal 2 mg 00363-1176-08 WALGREENS 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 00615-8497-39 NCS 30 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 11673-0177-12 TARGET 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 11822-7834-02 Rite 12 capsules — — FDA listed —
anti-diarrheal 2 mg 21130-0835-12 Albertsons 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 30142-0159-08 KROGER 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 36800-0208-12 TOP 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 37808-0988-12 HEB 12 capsules — — FDA listed —
anti-diarrheal 2 mg 41250-0210-08 MEIJER 12 capsules — — FDA listed —
First Aid Direct Anti-Diarrheal 2 mg 42961-0103-02 Cintas 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 43063-0020-12 PD-Rx 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 43598-0770-24 Dr. 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 48433-0063-20 Safecor 100 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 49035-0483-12 Wal-Mart 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 50090-0460-00 A-S 15 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 50090-7398-00 A-S 15 capsules — AB FDA listed —
Imodium A-D 2 mgthis 50580-0367-02 Kenvue 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 51407-0999-01 Golden 100 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 53943-0176-12 DISCOUNT 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 55154-4699-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 55154-5585-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 55289-0315-06 PD-Rx 6 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 55910-0176-08 DOLGENCORP, 12 capsules — — FDA listed —
anti-diarrheal 2 mg 56062-0680-12 PUBLIX 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 58602-0727-74 Aurohealth 6 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 60468-0005-01 allphamed 100 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 63629-8747-01 Bryant 100 capsules — AB FDA listed —
anti-diarrheal 2 mg 63941-0684-12 VALU 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 66267-0132-12 NuCare 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 67046-1676-03 Coupler 30 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 67296-2172-01 Redpharm 15 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 68016-0058-12 Premier 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 68071-2257-06 NuCare 6 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 68071-2700-01 NuCare 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 68071-3618-01 NuCare 12 capsules — AB FDA listed —
anti-diarrheal 2 mg 69452-0176-12 Bionpharma 24 capsules — — FDA listed —
anti-diarrheal 2 mg 69452-0266-12 Bionpharma 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 69842-0061-12 CVS 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 70518-4283-00 REMEDYREPACK 30 capsules — AB FDA listed —
Loperamide hydrochloride 2 mg 70771-1769-01 Zydus 100 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-1921-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2061-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2111-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2487-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2571-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0648-53 Aphena 60 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0781-53 Aphena 60 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0950-30 Aphena 30 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0973-53 Aphena 60 capsules — AB FDA listed —
anti-diarrheal 2 mg 72288-0313-12 Amazon.com 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 72888-0130-00 Advagen 1000 capsules — AB FDA listed —
WELMATE Anti Diarrheal Loperamide HCl Softgels 2 mg 73581-0102-24 YYBA 24 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 75907-0097-12 Dr. 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 80136-0851-42 Northeast 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 55154-0277-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 59556-0959-05 Strides 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 73581-0177-02 YYBA 12 capsules — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2016
On the market since
Jul 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Imodium A-D (this brand).

Top reported reactions

Diarrhoea8,805
Nausea4,255
Fatigue3,846
Vomiting2,747
Constipation2,438
Weight Decreased2,071
Headache1,994

Age at onset

Neonate13
Infant21
Child95
Adolescent98
Adult4,320
Elderly5,224

Reporter sex

44,211 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization15,989
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50580-0367-01 1 BLISTER PACK in 1 CARTON (50580-367-01) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2016-07-11 Active
50580-0367-02 You're viewing this 2 BLISTER PACK in 1 CARTON (50580-367-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2016-07-11 Active

Pack size FAQ

What quantity is in NDC 50580-0367-02?
NDC 50580-0367-02 is listed by the FDA — 2 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack.
What NDC number is used to bill for this package of Imodium A-D Loperamide Hydrochloride 2 mg Capsule, Liquid Filled?
Bill NDC 50580-0367-02 — the 11-digit billing format is 50580036702. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 50580-367-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50580-0367-02, written without dashes as 50580036702. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 50580-0367-02, the first segment (50580) is the labeler code FDA assigned to Kenvue Brands LLC; the middle segment (0367) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Kenvue Brands LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 12 capsules (50580-0367-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Kenvue Brands LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 8 words ▾

Use controls symptoms of diarrhea, including Travelers' Diarrhea

⏱️ Dosage and Administration 53 words ▾

Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea not for use in children under 12 years of age adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

⚠️ Warnings ~2 min read ▾

Warnings 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 in children under 12 years of age 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. 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 in children under 12 years of age 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.

📦 Storage and Handling 25 words ▾

Other information store at 20°-25°C (68°-77°F). Protect from light. avoid excessive heat above 40°C (104°F) do not use if blister unit is torn or broken

🧪 Active Ingredient 9 words ▾

Active ingredient (in each capsule) Loperamide HCl 2 mg

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients butylated hydroxyanisole, edible ink, FD&C blue no. 1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

🎯 Purpose 2 words ▾

Purpose Anti-diarrheal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50580-0364-01 · Kenvue 50580-0368-01 · Kenvue →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.