Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 507acd63-b2b4-465e-bb94-2d66724de20a
Route
ORAL
Published
Effective Date 2022-12-29
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 2019-01-01

Description

Loperamide HCI 2 mg

Purpose

Anti-diarrheal


Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCI 2 mg

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments plesae call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc., Bentoville, AR 72716

PRODUCT OF ITALY

All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Imodium ® A-D.

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.

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
  • 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
Do Not Use
  • if you have bloody or black stool
  • in children under 12 years of age
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

Questions Or Comments?

1-888-287-1915

Principal Display Panel

NDC 49035-483-12

equate TM

Compare to Imodium® A-D active ingredient

Loperamide HCl Soft Gelatin Capsules, 2 mg

Anti-Diarrheal

Liquid Softgels

  • Controls the symptoms of diarrhea
  • Suitable for adults and children 12 years and over

*Each liquid-filled capsule contains 2 mg Loperamide HCl

2 mg 24 SOFTGELS*

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 HCI 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

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5 (42229-5)

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments plesae call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc., Bentoville, AR 72716

PRODUCT OF ITALY

All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Imodium ® A-D.

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.

Purpose

Anti-diarrheal

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
  • 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
Do Not Use (Do not use)
  • if you have bloody or black stool
  • in children under 12 years of age
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

Questions Or Comments? (Questions or comments?)

1-888-287-1915

Principal Display Panel

NDC 49035-483-12

equate TM

Compare to Imodium® A-D active ingredient

Loperamide HCl Soft Gelatin Capsules, 2 mg

Anti-Diarrheal

Liquid Softgels

  • Controls the symptoms of diarrhea
  • Suitable for adults and children 12 years and over

*Each liquid-filled capsule contains 2 mg Loperamide HCl

2 mg 24 SOFTGELS*

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 HCI 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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