Loperamide Hydrochloride and Simethicone
2 mg + 125 mg · Tablet
- Available without prescription
- Opioid Agonist
- Active substance
- Loperamide Hydrochloride and Simethicone
- Made by
- FSA store INC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2025-04-05
Anti-diarrheal Anti-gas
- Relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
adults and children 12 years and over 2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours
Full directions ↓- Colour
- white
- Shape
- capsule
- Size
- 17 mm
- Imprint
- H · L21
- Score
- 2 parts
- Flavour
- vanilla
From the manufacturer’s submission to the FDA. Always compare with your own pack — a different maker’s tablet can look different.
- Sold without a prescription
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-01
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
From the official label · 2025-04-05 · DailyMed
Do not take it if
- if you have bloody or black stool
- if you have difficulty swallowing
Quoted from the official label, section “OTC — Do Not Use”.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours
- children 9-11 years (60-95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours
- children 6-8 years (48-59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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
Quoted from the official label, section “Dosage & Administration”.
Ask a doctor first if
- fever
- mucus in the stool
- a history of liver disease
- a history of abnormal heart rhythm
Quoted from the official label, section “OTC — Ask Doctor”.
Ask a pharmacist first if
you aretaking a prescription drug. Loperamide may interact with certain prescription drugs.
Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.
Stop and get help 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
Quoted from the official label, section “OTC — Stop Use”.
Other warnings
Allergy alert:Do not use 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
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
If pregnant or breast-feeding,ask a health professional before use.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Keep away from children
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Quoted from the official label, section “OTC — Keep Out of Reach of Children”.
What kind of medicine it is
Anti-diarrheal Anti-gas
Quoted from the official label, section “OTC — Purpose”.
Other ingredients
Relevant if you react to a dye, a preservative, lactose or gluten.
acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor
Quoted from the official label, section “Inactive Ingredients”.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
Canada1 matching products
Details
| Made by | FSA store INC |
|---|---|
| Active substance | Loperamide Hydrochloride and Simethicone |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Strength | 2 mg + 125 mg |
| Form | Tablet |
| Route | Oral |
| Packs | 4 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK |
| NDC | 81522-325 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
11 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet11 products
2 mg + 125 mg10
2 mg + 125 mg · 10 companies
- Aurohealth LLC
- Better Living Brands, LLC
- Bionpharma Inc.
- Camber Consumer Care Inc
- Family Dollar Stores, LLC
- FSA store INC · this page
- Granules India Ltd
- NORTHEAST PHARMA
- 125 mg + 2 mg
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.
See every product with Loperamide Hydrochloride and Simethicone