ANTI DIARRHEAL- loperamide hcl solution

Anti Diarrheal by

Drug Labeling and Warnings

Anti Diarrheal by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)

Loperamide HCl 1 mg

Purpose

Anti-diarrheal

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

Do not use

if you have bloody or black stool

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

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.

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

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

INGREDIENTS AND APPEARANCE

ANTI DIARRHEAL 
loperamide hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-978(NDC: 0113-0377)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	1 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	ORANGE (amber, clear, pale)	Score
Shape		Size
Flavor	CHERRY (cherry mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-978-04	1 in 1 CARTON
1		120 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073243	07/13/1992

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK