HANDY SOLUTIONS ANTI-DIARRHEAL- loperamide hydrochloride tablet

Handy Solutions Anti-Diarrheal by

Drug Labeling and Warnings

Handy Solutions Anti-Diarrheal by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

Loperamide Hydrochloride 2 mg

Purpose

Antidiarrheal

Uses

Controls the symptoms of diarrhea, including Traveler’s 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 stools

Ask a doctor before use if you have

a fever
mucus in 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 more than 2 days
you get abdominal swelling or bulging. These may be signs of a serious condition.

If you are pregnant or breast feeding,

ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, contact a physician or Poison Control Center right away.

Directions

do not use more than directed
drink plenty of clear fluids to help prevent dehydration caused by diarrhea

• Adults and children (12 years and older): Take 2 caplets after the first ; loose bowel movement ; followed by 1 caplet after each ; subsequent loose bowel ; movement but no more than ; 4 caplets in 24 hours.
• Children under 12 years: Do not give to children under ; 12 years of age.

Other information

store between 68º - 77ºF (20º - 25ºC)
tamper-evident sealed packets
do not use any opened or torn packet

Inactive ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow # 10, FD&C blue # 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions or comments?

1-800-525-5097

Package Labeling:

INGREDIENTS AND APPEARANCE

HANDY SOLUTIONS ANTI-DIARRHEAL 
loperamide hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-162(NDC:47682-200)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)

Product Characteristics
Color	green (green)	Score	2 pieces
Shape	OVAL (OVAL)	Size	10mm
Flavor		Imprint Code	123
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-162-01	1 in 1 CARTON	09/21/2016
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074091	09/21/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-162) , repack(67751-162)