Amerisource Bergen Loperamide Hydrochloride Oral Suspension Drug Facts

Amerisource Bergen Loperamide Hydrochloride Oral Suspension Drug Facts
SPL v4
SPL
SPL Set ID 0c9a897d-475c-425c-b2fa-5dfd68785e08
Route
ORAL
Published
Effective Date 2019-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (1 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium D&c Yellow No. 10 Fd&c Blue No. 1 Glycerin Cellulose, Microcrystalline Propylene Glycol Water Sodium Benzoate Sucralose Titanium Dioxide Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
ANDA Active Since 2019-02-26

Description

Loperamide HCl 1 mg

Purpose

Anti-diarrheal


Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl 1 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.
  • shake well before using
  • only use attached measuring cup to dose product

adults and children

12 years and over

30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hours

children 9-11 years

(60-95 lbs)

15 mL (3 tsp) after the first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 45 mL (9 tsp) in 24 hours

children 6-8 years

(48-59 lbs)

15 mL (3 tsp) after the first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 30 mL (6 tsp) in 24 hours

children under

6 years

(up to 47 lbs)

ask a doctor

Do Not Use

if you have bloody or black stool

Distributed By:

1-800-719-9260

Other Information
  • each 30 mL (6 tsp) contains: sodium 15 mg
  • store between 20-25°C (68-77°F)
  • see side panel for lot number and expiration date
Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

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 7.5 Ml)

Loperamide HCl 1 mg

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
  • a history of liver disease
Package/label Principal Display Panel

Compare to Imodium® A-D active ingredient

Loperamide Hydrochloride Oral Suspension

anti-diarrheal

Controls the Symptoms of Diarrhea

mint flavor

NDC 17856-0111-06

Ask A Doctor Or Pharmacist Before Use If You Are

taking antibiotics


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.
  • shake well before using
  • only use attached measuring cup to dose product

adults and children

12 years and over

30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hours

children 9-11 years

(60-95 lbs)

15 mL (3 tsp) after the first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 45 mL (9 tsp) in 24 hours

children 6-8 years

(48-59 lbs)

15 mL (3 tsp) after the first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 30 mL (6 tsp) 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

Distributed By: (DISTRIBUTED BY:)

1-800-719-9260

Other Information (Other information)
  • each 30 mL (6 tsp) contains: sodium 15 mg
  • store between 20-25°C (68-77°F)
  • see side panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

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 7.5 Ml) (Active ingredient (in each 7.5 mL))

Loperamide HCl 1 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
Package/label Principal Display Panel (Package/Label Principal Display Panel)

Compare to Imodium® A-D active ingredient

Loperamide Hydrochloride Oral Suspension

anti-diarrheal

Controls the Symptoms of Diarrhea

mint flavor

NDC 17856-0111-06

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

taking antibiotics


Advanced Ingredient Data


Raw Label Data

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