CRANE SAFETY ALLERGY RELIEF- loratadine tablet, film coated

Crane Safety Allergy Relief by

Drug Labeling and Warnings

Crane Safety Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Crane Safety LLC, Unifirst First Aid Corporation, Prestige Packaging. 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 ahealth professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poision 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.

Consumers with liver or kidney disease

Ask a doctor before using.

Other information

• store between 68º and 77ºF (20º and 25ºC )
• protect from excessive moisture
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions or comments?

877.506.4291

Crane Safety Allergy Relief Label

24-Hour

Allergy Relif

Non-Drowsy* Allergy Relief

CRANE Safety®

Pull to Open

Loratadine 10 MG

Packet is Not Child-Resistant

* When taken as directed. See Drug Facts Panel.

100 Tablets

Tamper Evident

Sealed Packets

INGREDIENTS AND APPEARANCE

CRANE SAFETY ALLERGY RELIEF 
loratadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73408-913(NDC:47682-913)
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	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RX;526
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73408-913-33	100 in 1 BOX	01/17/2020
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	01/17/2020

Labeler - Crane Safety LLC (080998015)

Registrant - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	relabel(73408-913) , repack(73408-913)