Active Ingredients And Purpose
Drug Facts
Active ingredient (in each tablet) Loperamide hydrochloride USP 2 mg
Purpose
Anti-diarrheal
Loperamide Hydrochloride
- Manufacturer
- Aurohealth LLC | Aurobindo Pharma Limited
- Effective date
- 2022-03-22
- Label type
- Human OTC Drug Label
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:48:55
Key Label Information
Uses
Use
controls symptoms of diarrhea, including Travelers' Diarrhea
Warnings
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
Do not use
if you have bloody or black stool
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.
Directions And Dosage
Directions
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. 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 to 11 years (60 to 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 to 8 years (48 to 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 to 5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use
Other Label Information
Other information
store at 20° to 25°C (68° to 77°F). do not use if carton or blister unit is open or torn Meets USP dissolution test 2 see side panel for lot number and expiration date
Inactive ingredients
colloidal silicon dioxide, D & C yellow No. 10 aluminum lake, FD & C blue No. 1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate
Questions or comments?
call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code .: TS/DRUGS/22/2009
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (4 x 6's Tablets)
Healthy Living ™ LOPERAMIDE hydrochloride tablets USP 2 mg Anti-Diarrheal Controls the symptoms of diarrhea 24 Tablets
Label Images
Products
- LOPERAMIDE
NDC Codes
Ingredients
Complete SPL Sections
Drug Facts
Active ingredient (in each tablet) Loperamide hydrochloride USP 2 mg
Purpose
Anti-diarrheal
Use
controls symptoms of diarrhea, including Travelers' Diarrhea
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
Do not use
if you have bloody or black stool
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 (1-800-222-1222) right away.
Directions
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. 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 to 11 years (60 to 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 to 8 years (48 to 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 to 5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use
Other information
store at 20° to 25°C (68° to 77°F). do not use if carton or blister unit is open or torn Meets USP dissolution test 2 see side panel for lot number and expiration date
Inactive ingredients
colloidal silicon dioxide, D & C yellow No. 10 aluminum lake, FD & C blue No. 1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate
Questions or comments?
call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code .: TS/DRUGS/22/2009
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (4 x 6's Tablets)
Healthy Living ™ LOPERAMIDE hydrochloride tablets USP 2 mg Anti-Diarrheal Controls the symptoms of diarrhea 24 Tablets
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
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- XML SHA-256
- 5acf9df6fde78188efa1d4245c4e3c88ffa0368a774538553f1e38767f5220f9
- XML bytes
- 27250
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 93ebbb23-a9f0-4519-9793-c9056be39f23.xml | 2022-03-26 |
| otc | loperamide-fig1.jpg | 2022-03-26 |