Imodium ®

Imodium ®
SPL v13
SPL
SPL Set ID 01da76d0-1979-4c45-9d39-c72ae4e4ffe2
Route
ORAL
Published
Effective Date 2021-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg)
Inactive Ingredients
Anhydrous Lactose Carnauba Wax Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: IMO;2;MG Shape: oval Color: white Size: 11 mm Score: 2
Marketing Status
ANDA Active Since 2015-07-13 Until 2021-10-31

Description

Drug Facts

Purpose

Anti-diarrheal


Medication Information

Purpose

Anti-diarrheal

Description

Drug Facts

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50567-7

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

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

Section 50570-1

Do not use if you have bloody or black stool

Section 53414-9

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

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 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets 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
Heart Alert

Taking more than directed can cause serious heart problems or death

Allergy Alert

Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Other Information
  • store at 20°-25°C (68°-77°F)
  • do not use if blister unit is broken or torn
Inactive Ingredients

anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions Or Comments?

1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Principal Display Panel

NDC 50580-317-06

Imodium ®

A-D

Loperamide Hydrochloride Tablets, 2mg

Anti-Diarrheal

Anti-Diarrheal

Caplets

Controls the symptoms

of diarrhea

Actual Size

*Capsule-Shaped Tablets

12 Caplets*

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.
Active Ingredient (in Each Caplet)

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

Structured Label Content

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

Section 50570-1 (50570-1)

Do not use if you have bloody or black stool

Section 53414-9 (53414-9)

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

Purpose

Anti-diarrheal

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 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets 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
Heart Alert (Heart alert)

Taking more than directed can cause serious heart problems or death

Allergy Alert (Allergy alert)

Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
  • do not use if blister unit is broken or torn
Inactive Ingredients (Inactive ingredients)

anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions Or Comments? (Questions or comments?)

1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-317-06

Imodium ®

A-D

Loperamide Hydrochloride Tablets, 2mg

Anti-Diarrheal

Anti-Diarrheal

Caplets

Controls the symptoms

of diarrhea

Actual Size

*Capsule-Shaped Tablets

12 Caplets*

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.
Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)