OTC Medication Information: LORATADINE

LORATADINE- loratadine tablet, orally disintegrating
CVS PHARMACY, INC

Drug Facts

Active ingredient (in each tablet)

Loratadine 10 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.

Directions

  • place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 6 years and over 1 tablet daily; not 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

Other information

  • safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally Disintegrating Tablet, USP is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister
  • complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration

Inactive ingredients

anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan

Questions or comments?

1-877-244-9825

Manufactured by:

Tenshi Kaizen Private Limited

Bengaluru Rural – 562112, India

Revised: 11/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health

Indoor & Outdoor Allergies

Children’s
LORATADINE ORALLY
DISINTEGRATING
TABLETS USP, 10 mg

Antihistamine

Allergy Relief

Non-Drowsy*

Original Prescription Strength

24 hour relief of:
Sneezing; Runny nose; Itchy,
watery eyes; Itchy throat or nose

Ages 6 yrs & older
30 ORALLY
DISINTEGRATING
TABLETS

image
(click image for full-size original)
LORATADINE
loratadine tablet, orally disintegrating
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-503
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
PULLULAN
POLYSORBATE 80
MANNITOL
Product Characteristics
Color white Score no score
Shape ROUND Size 12mm
Flavor MINT Imprint Code T10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51316-503-02 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (51316-503-02)
2 NDC:51316-503-03 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (51316-503-03)
3 NDC:51316-503-05 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 50 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (51316-503-05)
4 NDC:51316-503-06 6 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (51316-503-06)
5 NDC:51316-503-04 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 40 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (51316-503-04)
6 NDC:51316-503-01 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (51316-503-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213294 06/06/2021
Labeler — CVS PHARMACY, INC (062312574)
Establishment
Name Address ID/FEI Operations
Tenshi Kaizen Pvt Ltd 675478488 analysis (51316-503), manufacture (51316-503), pack (51316-503)

Revised: 06/2021 CVS PHARMACY, INC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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