HANDY SOLUTIONS 24 HOUR ALLERGY- loratadine tablet, film coated

Handy Solutions 24 Hour Allergy by

Drug Labeling and Warnings

Handy Solutions 24 Hour Allergy 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 tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
 runny nose
 itchy, watery eyes
 sneezing
 itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

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

Adults and children (12 years and older): 1 tablet daily; not more than 1 tablet in 24 hours

Children under 12 years: do not give to children under 12 years of age

Consumer with liver or kidney disease: ask a doctor before using

Other information

Tamper evident sealed packets
 Do not use any opened or torn packets
 Store between 68°F and 77°F (20° and 25°C)
 Protect from excessive moisture

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions or comments?

call 1-800-525-5097

Package Labeling:

INGREDIENTS AND APPEARANCE

HANDY SOLUTIONS 24 HOUR ALLERGY 
loratadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-163(NDC:47682-203)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	RX;526
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-163-01	1 in 1 CARTON	09/22/2016
1		6 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67751-163-02	1 in 1 CARTON	09/22/2016
2		2 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	ANDA076134	09/22/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-163) , repack(67751-163)