LEADER ALLERGY RELIEF- loratadine tablet

Leader Allergy Relief by

Drug Labeling and Warnings

Leader Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110, LLC. dba Leader. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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. (1-800-222-1222)

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

• do not use if printed foil under cap is broken or missing
• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

Non-Drowsy* | 24 Hour

Allergy Relief

Loratadine Tablets, 10 mg | Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of:

Sneezing; Runny Nose;

Itchy, Watery Eyes;

Itchy Throat or Nose

COMPARE TO CLARITIN

active ingredient

Original Prescription Strength

100% Money Back Guarantee

300 TABLETS

Actual Size

*When taken as directed.

See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

LEADER ALLERGY RELIEF 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0213
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)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	L612
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0213-2	30 in 1 CARTON	12/09/2016
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 70000-0213-3	1 in 1 CARTON	12/09/2016
2		70 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 70000-0213-4	1 in 1 CARTON	12/09/2016
3		90 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 70000-0213-1	10 in 1 CARTON	12/09/2016
4		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 70000-0213-5	40 in 1 CARTON	12/13/2017
5		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 70000-0213-6	1 in 1 CARTON	01/14/2020
6		300 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076301	12/09/2016

Labeler - Cardinal Health (097537435)