Loratadine

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 2018-05-01

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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

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.

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

Questions?

1-888-287-1915

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

Active Ingredient (in Each Tablet)

Loratadine USP, 5 mg

Principal Display Panel 5 Mg Tablet Blister Pack Carton

NDC 49035-953-30

equate™

Compare to

Children's Claritin®

Chewables active

ingredient*

children ^★s Non-Drowsy**

LORATADINE CHEWABLE

Tablets USP, 5mg

Antihistamine

24

HOURS

AGES 2 YEARS AND OLDER

Indoor & Outdoor Allergies

Grape Flavored

30 Chewable Tablets

The chewable tablets are to be chewed before swallowing.

Relief of:

Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose

**When taken as directed.

See Drug Facts Panel.

Structured Label Content

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

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.

Purpose

Antihistamine

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

Questions?

1-888-287-1915

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Loratadine USP, 5 mg

Principal Display Panel 5 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton)

NDC 49035-953-30

equate™

Compare to

Children's Claritin®

Chewables active

ingredient*

children ^★s Non-Drowsy**

LORATADINE CHEWABLE

Tablets USP, 5mg

Antihistamine

24

HOURS

AGES 2 YEARS AND OLDER

Indoor & Outdoor Allergies

Grape Flavored

30 Chewable Tablets

The chewable tablets are to be chewed before swallowing.

Relief of:

Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose

**When taken as directed.

See Drug Facts Panel.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "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).", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "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", "Questions?": "1-888-287-1915", "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", "Active ingredient (in each tablet)": "Loratadine USP, 5 mg", "PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton": "NDC 49035-953-30 equate™ Compare to Children's Claritin® Chewables active ingredient* children ★ s Non-Drowsy** LORATADINE CHEWABLE Tablets USP, 5mg Antihistamine 24 HOURS AGES 2 YEARS AND OLDER Indoor & Outdoor Allergies Grape Flavored 30 Chewable Tablets The chewable tablets are to be chewed before swallowing. Relief of: Sneezing Runny nose Itchy, watery eyes Itchy throat or nose **When taken as directed. See Drug Facts Panel."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information