Loperamide Hydrochloride

Loperamide Hydrochloride
SPL v1
SPL
SPL Set ID a732a67c-bce1-4521-9df4-69709fdf537d
Route
ORAL
Published
Effective Date 2016-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg)
Inactive Ingredients
Anhydrous Lactose Carnauba Wax Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycols

Identifiers & Packaging

Pill Appearance
Imprint: L2 Shape: capsule Color: green Size: 10 mm Score: 2
Marketing Status
ANDA Active Since 2003-06-27

Description

Loperamide HCl 2 mg

Purpose

Anti-diarrheal


Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl 2 mg

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

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

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 under 6 years (up to 47 lbs) ask a doctor
Do Not Use

if you have bloody or black stool

Other Information
  • store at 20°-25°C (68°-77°F)
  • do not use if printed foil under cap is broken or missing
  • see end panel for lot number and expiration date
Inactive Ingredients

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

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. (1-800-222-1222)

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
Ask A Doctor Or Pharmacist Before Use If You Are

taking antibiotics

Principal Display Panel 2 Mg Tablet Blister Pack Carton Label

CommUnityCare Federally Qualified Health Centers

LOPERAMIDE

2MG Tablet

#12

Date:

Name:

Dr.

TAKE AS DIRECTED.

123456

1/1/01

LOPERAMIDE 2MG Tablet #12 NDC 76413-314-12

Batch: 123456

Lot: 123456

Exp: 1/1/01

SUNMARK

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.


Structured Label Content

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Purpose

Anti-diarrheal

Warnings

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

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 under 6 years (up to 47 lbs) ask a doctor
Do Not Use (Do not use)

if you have bloody or black stool

Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
  • do not use if printed foil under cap is broken or missing
  • see end panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

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. (1-800-222-1222)

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

taking antibiotics

Principal Display Panel 2 Mg Tablet Blister Pack Carton Label (PRINCIPAL DISPLAY PANEL - 2 MG Tablet Blister Pack Carton Label)

CommUnityCare Federally Qualified Health Centers

LOPERAMIDE

2MG Tablet

#12

Date:

Name:

Dr.

TAKE AS DIRECTED.

123456

1/1/01

LOPERAMIDE 2MG Tablet #12 NDC 76413-314-12

Batch: 123456

Lot: 123456

Exp: 1/1/01

SUNMARK

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.


Advanced Ingredient Data


Raw Label Data

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