Loperamide Hydrochloride Tablets Usp, 2mg

SPL v3

SPL

SPL Set ID 644fb37a-1d97-4333-a5c7-5a485ab338f7

Route

ORAL

Published

Effective Date 2025-02-17

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Loperamide (2 mg)

Inactive Ingredients

Carnauba Wax Silicon Dioxide Croscarmellose Sodium Hydroxypropyl Methylcellulose Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: L;2 Shape: capsule Color: white Size: 10 mm Score: 2

Marketing Status

ANDA Active Since 2025-11-19

Description

Active ingredient (in each tablet) Loperamide HCl USP, 2 mg

Purpose

Purpose Anti-diarrheal

Medication Information

Purpose

Purpose

Anti-diarrheal

Description

Active ingredient (in each tablet) Loperamide HCl USP, 2 mg

Use(s)

Use controls symptoms of diarrhea, including Travelers' Diarrhea

Storage

Other information

• store at 20°-25°C (68°-77°F)

• do not use if carton or blister unit is open or torn

• FDA approved dissolution test specifications differ from USP

Warnings

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

Directions

Direction s

• 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 9-11 years (60-95 lbs)	1 tablet after the first loose stool; ½ 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; ½ 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

Do Not Use

Do not use if you have bloody or black stool

Active Ingredient(s)

Active ingredient (in each tablet)

Loperamide HCl USP, 2 mg

Inactive Ingredients

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hydroxy propyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions Or Comments?

Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)

Manufactured for: Time-Cap Labs, Inc.

7 Michael Avenue, Farmingdale, NY 11735

Manufactured by: Marksans Pharma Ltd.

Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa-403722

MADE IN INDIA

Pregnancy/breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel

NDC: 25000-001-83

Loperamide Hydrochloride Tablets USP, 2mg

24's count blister carton

When Using This Product

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Ask A Doctor Before Use If

Ask 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 and Ask Doctor If

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.

Keep Out of Reach of Children

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).

Ask A Doctor Or Pharmacist Before Use If

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Loperamide may interact with certain prescription drugs.

Structured Label Content

Use(s) (USE(S))

Use controls symptoms of diarrhea, including Travelers' Diarrhea

Purpose (PURPOSE)

Purpose

Anti-diarrheal

Storage (STORAGE)

Other information

• store at 20°-25°C (68°-77°F)

• do not use if carton or blister unit is open or torn

• FDA approved dissolution test specifications differ from USP

Warnings (WARNINGS)

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

Directions (DIRECTIONS)

Direction s

• 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 9-11 years (60-95 lbs)	1 tablet after the first loose stool; ½ 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; ½ 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

Do Not Use (DO NOT USE)

Do not use if you have bloody or black stool

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Active ingredient (in each tablet)

Loperamide HCl USP, 2 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)

Manufactured for: Time-Cap Labs, Inc.

7 Michael Avenue, Farmingdale, NY 11735

Manufactured by: Marksans Pharma Ltd.

Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa-403722

MADE IN INDIA

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC: 25000-001-83

Loperamide Hydrochloride Tablets USP, 2mg

24's count blister carton

When Using This Product (WHEN USING THIS PRODUCT)

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)

Ask 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 and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

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.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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).

Ask A Doctor Or Pharmacist Before Use If (ASK A DOCTOR OR PHARMACIST BEFORE USE IF)

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Loperamide may interact with certain prescription drugs.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"USE(S)": "Use controls symptoms of diarrhea, including Travelers' Diarrhea", "PURPOSE": "Purpose Anti-diarrheal", "STORAGE": "Other information • store at 20°-25°C (68°-77°F) • do not use if carton or blister unit is open or torn • FDA approved dissolution test specifications differ from USP", "WARNINGS": "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", "DIRECTIONS": "Direction s • 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 9-11 years (60-95 lbs) 1 tablet after the first loose stool; ½ 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; ½ 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", "DO NOT USE": "Do not use if you have bloody or black stool", "ACTIVE INGREDIENT(S)": "Active ingredient (in each tablet) Loperamide HCl USP, 2 mg", "INACTIVE INGREDIENTS": "Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hydroxy propyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.", "QUESTIONS OR COMMENTS?": "Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM) Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735 Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa-403722 MADE IN INDIA", "PREGNANCY/BREASTFEEDING": "If pregnant or breast-feeding, ask a health professional before use.", "PRINCIPAL DISPLAY PANEL": "NDC: 25000-001-83 Loperamide Hydrochloride Tablets USP, 2mg 24's count blister carton", "WHEN USING THIS PRODUCT": "When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.", "ASK A DOCTOR BEFORE USE IF": "Ask 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 AND ASK DOCTOR IF": "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.", "KEEP OUT OF REACH OF CHILDREN": "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).", "ASK A DOCTOR OR PHARMACIST BEFORE USE IF": "Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:17.947641 · Updated: 2026-03-14T23:10:34.945513