loratadine

loratadine
SPL v3
SPL
SPL Set ID 645c26ab-08ab-4a69-ae7d-7802d8ec5922
Route
oral
Published
Effective Date 2019-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
loratadine (5 mg)
Inactive Ingredients
aspartame anhydrous citric acid silicon dioxide d&c red no. 27 fd&c blue no. 2 magnesium stearate mannitol microcrystalline cellulose stearic acid sodium starch glycolate type a potato

Identifiers & Packaging

Pill Appearance
Imprint: 753 Shape: round Color: purple Size: 10 mm Score: 1
Marketing Status
anda active Since 2019-07-26

Purpose

Antihistamine

Description

Drug Facts


Medication Information

Active Ingredient

Loratadine USP, 5 mg

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
Purpose

Antihistamine

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 1.25 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, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Description

Drug Facts

Questions?

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

Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50566-9

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Principal Display Panel 30 Tablet Blister Pack Carton

Walgreens

children's

ALLERGY

Wal-itin ®

LORATADINE CHEWABLE TABLETS USP, 5 mg / ANTIHISTAMINE

Compare to Children's Claritin ®

Chewables active ingredient ††

NDC 0363-0752-30

NEW

CHEWABLE

NON-DROWSY*

24-HOUR RELIEF

  • 24-hour relief of sneezing, runny nose,

    itchy throat or nose, & itchy, watery eyes
  • Indoor & outdoor allergies

30 CHEWABLE

TABLETS

The chewable tablets are to be chewed before swallowing.

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

GRAPE

FLAVOR

ACTUAL SIZE

AGES

2

YEARS &

OLDER


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Loratadine USP, 5 mg

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
Purpose

Antihistamine

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 (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 (Inactive ingredients)

aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, 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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50566-9 (50566-9)

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Principal Display Panel 30 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton)

Walgreens

children's

ALLERGY

Wal-itin ®

LORATADINE CHEWABLE TABLETS USP, 5 mg / ANTIHISTAMINE

Compare to Children's Claritin ®

Chewables active ingredient ††

NDC 0363-0752-30

NEW

CHEWABLE

NON-DROWSY*

24-HOUR RELIEF

  • 24-hour relief of sneezing, runny nose,

    itchy throat or nose, & itchy, watery eyes
  • Indoor & outdoor allergies

30 CHEWABLE

TABLETS

The chewable tablets are to be chewed before swallowing.

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

GRAPE

FLAVOR

ACTUAL SIZE

AGES

2

YEARS &

OLDER


Advanced Ingredient Data


Raw Label Data

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