Loratadine by STRATEGIC SOURCING SERVICES LLC / Taro Pharmaceuticals Inc. LORATADINE solution

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by STRATEGIC SOURCING SERVICES LLC, Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 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 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 ifan 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

• use only with enclosed dosing cup

• adults and children 6 years and over: 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
• children 2 to under 6 years of age: 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
• children under 2 years of age: ask a doctor
• consumers with liver or kidney disease: ask a doctor

Other information

• do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
• see bottom panel for lot number and expiration date
• store between 20° and 25°C (68° and 77°F)

Inactive ingredients

artificial peach flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Questions?

call 833-358-6431

SPL UNCLASSIFIED SECTION

Distributed by:McKesson Corp.,
via Strategic Sourcing Services LLC.
Memphis, TN 38141

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC: 70677-1057-1

COMPARE TO CHILDREN'S
CLARITIN ®ACTIVE INGREDIENT*

Foster & Thrive™

ORIGINAL PRESCRIPTION STRENGTH

Children's
Allergy

Loratadine Oral Solution
USP, 5 mg/5 mL
ANTIHISTAMINE Allergy

Indoor & Outdoor Allergies
24 hour relief of:

• Runny Nose
• Itchy, Watery Eyes
• Sneezing
• Itchy Throat or Nose

Non-Drowsy**

WARNING: Contains sodium metabisulfite,
a sulfite that may cause allergic-type reactions.

Ages 2 years & older
Dye Free
FRUIT FLAVOR
DOSING CUP ENCLOSED

** WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

4 FL OZ (120 mL)

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1057
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow (colorless to slightly yellow)	Score
Shape		Size
Flavor	FRUIT (peach)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1057-1	1 in 1 CARTON	08/01/2023
1		120 mL 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	ANDA076805	08/01/2023

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharma Canada Inc.		243339023	manufacture(70677-1057)