LOPERAMIDE HYDROCHLORIDE 2MG- loperamide hydrochloride tablets usp, 2mg tablet

Loperamide Hydrochloride 2mg by

Drug Labeling and Warnings

Loperamide Hydrochloride 2mg by is a Otc medication manufactured, distributed, or labeled by MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

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

PURPOSE

Purpose 
Anti-diarrheal

USE(S)

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 HCl

Heart alert: Taking more than directed can cause serious heart problems or death

DO NOT USE

Do not use if you have bloody or black stool

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

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.

WHEN USING THIS PRODUCT

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

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.

PREGNANCY/BREASTFEEDING

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

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).

DIRECTIONS

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 9-11 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

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

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

PRINCIPAL DISPLAY PANEL

NDC: 25000-001-83

Loperamide Hydrochloride Tablets USP, 2mg
24's count blister carton

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE 2MG 
loperamide hydrochloride tablets usp, 2mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Loperamide Hydrochloride (UNII: 77TI35393C) (Loperamide - UNII:6X9OC3H4II)	Loperamide Hydrochloride	2 mg

Inactive Ingredients
Ingredient Name	Strength
carnauba wax (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
croscarmellose sodium (UNII: M28OL1HH48)
HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)
lactose monohydrate (UNII: EWQ57Q8I5X)
magnesium stearate (UNII: 70097M6I30)
microcrystalline cellulose (UNII: OP1R32D61U)
polyethylene glycol (UNII: 3WJQ0SDW1A)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (white to off-white)	Score	2 pieces
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	L;2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-001-83	4 in 1 CARTON	11/19/2025
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA220153	11/19/2025

Labeler - MARKSANS PHARMA LIMITED (925822975)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	MANUFACTURE(25000-001)