CAREALL LORATADINE- loratadine tablet

CAREALL Loratadine by

Drug Labeling and Warnings

CAREALL Loratadine by is a Otc medication manufactured, distributed, or labeled by New World Imports. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Loratadine 10mg

PURPOSE

Antihistamine

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)

INDICATIONS & USAGE

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

runny nose, itchy, watery eys, 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.

DOSAGE & ADMINISTRATION

Adult and children over 6 years old: 1 tablets daily: no 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

INACTIVE INGREDIENT

lactose monohydrate, magnesium stearate, sodium starch glycolate.  May contain: microcrystalline cellulose, pregelatinized starch

OTHER SAFETY INFORMATION

Store between 20-25 degrees celcius (68-77 degrees farhenheit).

Protect from excessive moisture

Do not use if imprinted seal under bottle cap is broken or missing

You may report side effects 1-888-952-0050

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-075
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (White to off white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	GG296;G;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-075-01	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210722	03/02/2020

Labeler - New World Imports (075372276)

Registrant - New World Imports (075372276)