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
sneezing
itchy, watery eyes
itching of the nose or throat

Warnings

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

When using this productdo 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

store between 20 to 25°C (68 to 77°F)
retain carton for complete product information and warnings

Inactive ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate

Questions or comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

First Street®

NDC 61504-193-19

†COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN®

NON-DROWSY*

Allergy Relief

24 HOUR

Loratadine Tablets

10 mg / Antihistamine

INDOOR & OUTDOOR ALLERGIES

For Relief of:

Sneezing • Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL

ACTUAL SIZE

30 TABLETS

image description

ALLERGY RELIEF
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61504-193
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white (white to off white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	G;10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61504-193-19	1 in 1 CARTON	10/30/2023
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:61504-193-20	1 in 1 CARTON	10/30/2023
2		90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA210722	10/30/2023

Labeler - AMERIFOODS TRADING COMPANY (626388680)

1193-FIR-2023-1101