381

381
SPL v7
SPL
SPL Set ID 0ecca2cd-c971-47b2-a2ac-ae7842dd4264
Route
ORAL
Published
Effective Date 2013-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg)
Inactive Ingredients
Starch, Corn D&c Yellow No. 10 Fd&c Blue No. 1 Magnesium Stearate Silicon Dioxide Cellulose, Microcrystalline Dibasic Calcium Phosphate Dihydrate

Identifiers & Packaging

Pill Appearance
Imprint: 44375 Shape: capsule Color: green Size: 7 mm Score: 2
Marketing Status
ANDA Active Since 2006-01-01

Description

Loperamide HCI 2 mg

Purpose

Anti-diarrheal


Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCI 2 mg

Uses

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 50565-1

Keep out of reach of children. In case of overdose, get medical

help or contact a Poison Control Center right away.

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI

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

Do not use if you have bloody or black stool

Ask a doctor before use if you have

  • a fever
  • mucus present in your 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.

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

Stop use and ask a doctor if

  • diarrhea lasts for more than 2 days
  • symptoms get worse
  • 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.

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 (34-47 lbs) ask a doctor
children under 2 years (up to 33 lbs) do not use
Package Label

Other Information
  • each caplet contains: calcium 15 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate,

FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments?

call 1-800-540-3765

Active Ingredient(in Each Caplet)

Loperamide HCI 2 mg


Structured Label Content

Uses

controls symptoms of diarrhea, including Travelers' Diarrhea

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.

Purpose

Anti-diarrheal

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI

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

Do not use if you have bloody or black stool

Ask a doctor before use if you have

  • a fever
  • mucus present in your 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.

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

Stop use and ask a doctor if

  • diarrhea lasts for more than 2 days
  • symptoms get worse
  • 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.

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 (34-47 lbs) ask a doctor
children under 2 years (up to 33 lbs) do not use
Package Label (package Label)

Other Information
  • each caplet contains: calcium 15 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate,

FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments? (Questions or comments?)

call 1-800-540-3765

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

Loperamide HCI 2 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)