loperamide hcl capsules 2mg

loperamide hcl capsules 2mg
SPL v2
SPL
SPL Set ID fed347ad-cfbb-9ee8-e053-6394a90ad275
Route
oral
Published
Effective Date 2023-10-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
loperamide (2 mg)
Inactive Ingredients
butylated hydroxyanisole fd&c blue no. 1 gelatin glycerin glyceryl caprylate polyoxyl 40 hydrogenated castor oil water

Identifiers & Packaging

Pill Appearance
Imprint: LP2 Shape: capsule Color: blue Size: 10 mm Score: 1
Marketing Status
nda active Since 2023-10-10

Purpose

Anti-diarrheal

Description

Loperamide HCl 2 mg


Medication Information

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

Purpose

Anti-diarrheal

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
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 carton or blister unit is open or torn
  • see side panel for lot number and expiration date
Inactive Ingredients

butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

Description

Loperamide HCl 2 mg

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distrbuted by the owners of Imodium ®A-D

Call 1-844-292-1112 for more product information.

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

L000072152

Lot #

Expiration Date

R0523

Do Not Use
  • if you have bloody or black stool
  • in children under 12 years of age
Carton 24's Count

Best

Choice®

Compare to the

active ingredient in

Imodium ®A-D*

Loperamide HCl

Capsules, 2 mg

ANTI-DIARRHEAL

Controls the

symptoms of diarrhea

SUITABLE FOR ADULTS AND CHILDERN

12 YEARS AND OVER

24

SOFTGELS*

*SOFT HELATIN LIQUID-FILLED CAPSULES

EACH SOFTGEL CONTAINS 2 mg LOPERAMIDE HCl

Questions Or Comments?

call toll free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)

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.

Active Ingredient (in Each Capsule)

Loperamide HCl 2 mg

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.


Structured Label Content

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

Purpose

Anti-diarrheal

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
Other Information (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 carton or blister unit is open or torn
  • see side panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5 (42229-5)

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distrbuted by the owners of Imodium ®A-D

Call 1-844-292-1112 for more product information.

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

L000072152

Lot #

Expiration Date

R0523

Do Not Use (Do not use)
  • if you have bloody or black stool
  • in children under 12 years of age
Carton 24's Count (Carton 24's count)

Best

Choice®

Compare to the

active ingredient in

Imodium ®A-D*

Loperamide HCl

Capsules, 2 mg

ANTI-DIARRHEAL

Controls the

symptoms of diarrhea

SUITABLE FOR ADULTS AND CHILDERN

12 YEARS AND OVER

24

SOFTGELS*

*SOFT HELATIN LIQUID-FILLED CAPSULES

EACH SOFTGEL CONTAINS 2 mg LOPERAMIDE HCl

Questions Or Comments? (Questions or comments?)

call toll free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)

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 A 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.
If Pregnant Or Breast Feeding, (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.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Loperamide HCl 2 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking a prescription drug. Loperamide may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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