Amazon Allergy Relief Drug Facts

Amazon Allergy Relief Drug Facts
SPL v2
SPL
SPL Set ID 2a834b33-5759-4e54-9adc-379310656dee
Route
ORAL
Published
Effective Date 2020-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Fd&c Blue No. 1 Gelatin, Unspecified Glycerin Hypromellose, Unspecified Isopropyl Alcohol Mannitol Propylene Glycol Water Sorbitan Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 446 Shape: oval Color: blue Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2020-03-12

Description

Loratadine 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine 10 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
Directions

adults and children 6 years and over

1 capsule daily; not more than 1 capsule in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information
  • do not use if blister unit is broken or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from freezing
Inactive Ingredients

FD&C blue no.1, gelatin, glycerin, hydrolyzed collagen, hypromellose, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments?

1-800-719-9260

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).

Active Ingredient (in Each Capsule)

Loratadine 10 mg

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Package/label Principal Display Panel

Original Prescription Strength

Compare to Claritin® Liqui-Gels® active ingredient

Allergy Relief

Loratadine Capsules, 10 mg

Antihistamine

Indoor & Outdoor Allergies

Non-Drowsy*

24 Hour Relief of:

Sneezing – Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Liquid-Gels

*When taken as directed. See Drug Facts Panel.

actual size

30 LIQUID-FILLED CAPSULES


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
Purpose

Antihistamine

Directions

adults and children 6 years and over

1 capsule daily; not more than 1 capsule in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information (Other information)
  • do not use if blister unit is broken or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from freezing
Inactive Ingredients (Inactive ingredients)

FD&C blue no.1, gelatin, glycerin, hydrolyzed collagen, hypromellose, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)

do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Loratadine 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease. Your doctor should determine if you need a different dose.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Original Prescription Strength

Compare to Claritin® Liqui-Gels® active ingredient

Allergy Relief

Loratadine Capsules, 10 mg

Antihistamine

Indoor & Outdoor Allergies

Non-Drowsy*

24 Hour Relief of:

Sneezing – Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Liquid-Gels

*When taken as directed. See Drug Facts Panel.

actual size

30 LIQUID-FILLED CAPSULES


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)