DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable

Dye-Free Childrens Loratadine by

Drug Labeling and Warnings

Dye-Free Childrens Loratadine by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC, Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable tablet)

Loratadine USP, 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

• chew or crush tablets completely before swallowing.

• adults and children 6 years and over: chew 2 tablets daily; not more than 2 chewable tablets in 24 hours
• children 2 to under 6 years of age: chew 1 tablet daily; not more than 1 chewable 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 1.25 mg per tablet.
• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
• store between 20° to 25°C (68° to 77°F).

Inactive ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

CVS
Health ®

Compare to the active ingredient in
Children's Claritin ®Chewables †

Indoor & Outdoor Allergies

NDC: 51316-821-20

Children's

Allergy Relief

LORATADINE CHEWABLE
TABLETS USP, 5 mg
Antihistamine

Non-Drowsy*

• 24 hour relief of:
  Sneezing; Runny nose; Itchy,
  watery eyes; Itchy throat or nose
• Ages 2+ years
• Dye free

*When taken as directed.
See Drug Facts Panel

Actual
Size

Grape
Flavor

20 CHEWABLE TABLETS
The chewable tablets are to be chewed before swallowing.

24
HOUR

INGREDIENTS AND APPEARANCE

DYE-FREE CHILDRENS LORATADINE 
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-821
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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	ROUND (beveled edge)	Size	10mm
Flavor	GRAPE	Imprint Code	LC5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-821-20	2 in 1 CARTON	03/15/2024
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51316-821-30	3 in 1 CARTON	03/15/2024
2		10 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	ANDA210088	03/15/2024

Labeler - CVS PHARMACY, INC (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	manufacture(51316-821)