Rite Aid Corporation Anti-diarrheal Drug Facts

Rite Aid Corporation Anti-diarrheal Drug Facts
SPL v1
SPL
SPL Set ID 4339d964-1997-4c0e-973e-aa69b123b33d
Route
ORAL
Published
Effective Date 2009-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (1 mg)
Inactive Ingredients
Alcohol Benzoic Acid Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Benzoate Sorbitol Sucrose

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
ANDA Active Since 1992-07-13

Description

Loperamide HCl 1 mg

Purpose

Anti-diarrheal


Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl 1 mg

Uses

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.
  • only use attached measuring cup to dose product
adults and children 12 years and over 4 teaspoonfuls (1 dosage cup) after the first loose stool; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose stool; but no more than 8 teaspoonfuls in 24 hours
children 9-11 years (60-95 lbs) 2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 6 teaspoonfuls in 24 hours
children 6-8 years (48-59 lbs) 2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 4 teaspoonfuls 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
  • do not use if carton is opened or if printed plastic neckband is broken or missing
  • store between 20°-25°C (68°-77°F)
  • see bottom panel for lot number and expiration date
Inactive Ingredients

alcohol (0.5%), benzoic acid, citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

Questions Or Comments?

1-800-719-9260

Principal Display Panel
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 5 Ml)

Loperamide HCl 1 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


Structured Label Content

Uses

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.
  • only use attached measuring cup to dose product
adults and children 12 years and over 4 teaspoonfuls (1 dosage cup) after the first loose stool; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose stool; but no more than 8 teaspoonfuls in 24 hours
children 9-11 years (60-95 lbs) 2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 6 teaspoonfuls in 24 hours
children 6-8 years (48-59 lbs) 2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 4 teaspoonfuls 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)
  • do not use if carton is opened or if printed plastic neckband is broken or missing
  • store between 20°-25°C (68°-77°F)
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

alcohol (0.5%), benzoic acid, citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel
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 5 Ml) (Active ingredient (in each 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
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

All Sections (JSON)