CHILDRENS ALLERGY RELIEF- loratadine tablet, chewable

childrens allergy relief by

Drug Labeling and Warnings

childrens allergy relief by is a Otc medication manufactured, distributed, or labeled by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. 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

• chew or crush tablets completely before swallowing

• 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

CVS Health®

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

Indoor & Outdoor Allergies

Children’s Allergy Relief

LORATADINE CHEWABLE TABLETS USP, 5 mg/Antihistamine

Non-Drowsy†

24 HOUR

Non-Drowsy† relief of:

Sneezing

Runny nose

Itchy, watery eyes

Itchy throat or nose

Ages 2 yrs & older

Actual Size

Grape Flavor

10 CHEWABLE TABLETS

†When taken as directed.

See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF 
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-133
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)
MICROCRYSTALLINE CELLULOSE (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: 51316-133-52	10 in 1 CARTON	06/06/2024
1		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	06/06/2024

Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)