FIRST AID DIRECT ALLERGY RELIEF- loratadine tablets tablet

First Aid Direct Allergy Relief by

Drug Labeling and Warnings

First Aid Direct Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation, Granules India Limitied. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporatily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose 
• itchy, watery eyes
• sneezing
• iching 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 accidental overdose, contact a doctor or Poison Control Center immediately. 

Directions

• adults and children 6 years and over​: 1 tablet daily; not more than 1 tablet in 24 hours
• children under 6 years of age: ask a doctor
• consumers with liver or kidney disease: ask a doctor

Other information

• store between 20°C to 25°C (68° to 77°F)
• protect from excessive moisture
• do not use if blister unit is torn or open

Inactive ingredients

lactose monohydrate, magensium stearate, pregelatinized starch, sodium startch glycolate

Questions?

1-800-327-2704 Monday - Friday 8:00am - 5:00pm (CDT)

Principal Display Panel

Original Prescription Strength

Non-Drowsy*

Allergy Relief

Loratadine Tablets, 10 mg - Antihistamine

Indoor & Outdoor Allergies

†Compare to active ingredient of Claritin®

Relief of:

• sneezing 
• runny nose
• itchy, watery eyes
• itchy throat or nose

24 Hour

Actual Size

20 TABLETS 

*When taken as directed. See drug facts panel

INGREDIENTS AND APPEARANCE

FIRST AID DIRECT ALLERGY RELIEF 
loratadine tablets tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-120
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	439
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-120-02	2 in 1 BOX	10/20/2021
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210722	10/20/2021

Labeler - Cintas Corporation (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limitied		918609236	manufacture(42961-120)