CAREONE CHILDRENS ALLERGY RELIEF- loratadine tablet, chewable

careone childrens allergy relief by

Drug Labeling and Warnings

careone childrens allergy relief by is a Otc medication manufactured, distributed, or labeled by American Sales Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

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 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:

  chew 2 tablets daily; not more than 2 tablets in 24 hours

• children 2 to under 6 years of age:

  chew 1 tablet daily; not more than 1 tablet in 24 hours

• children under 2 years of age:

  ask a doctor

• consumers with liver or kidney disease:

  ask a doctor

Other information

• phenylketonurics: contains phenylalanine 1.4 mg per tablet
• do not use if blister unit is broken or torn
• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Children’s Claritin® Chewables

For Ages 2 and Older

Children’s Allergy Relief

Loratadine Chewable Tablets, 5 mg Antihistamine

Actual Size

GRAPE FLAVOR

24hr

Non-Drowsy* / 24 HOUR RELIEF OF:

Sneezing - Runny Nose - Itchy, Watery Eyes

Itchy Throat Or Nose

Indoor & Outdoor Allergies

*When taken as directed. See Drug Facts Panel.

OUR PHARMACISTS RECOMMEND

20 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

CAREONE CHILDRENS ALLERGY RELIEF 
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-716
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	PURPLE (light)	Score	no score
Shape	ROUND	Size	8mm
Flavor	GRAPE	Imprint Code	L3Y8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-716-01	20 in 1 CARTON	07/19/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41520-716-39	30 in 1 CARTON	07/16/2019
2		1 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	ANDA210033	07/16/2019

Labeler - American Sales Company (809183973)