Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c3413e54-489c-036f-e053-2995a90a8087
Route
ORAL
Published
Effective Date 2021-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Caprylic/capric Mono/di-glycerides Fd&c Blue No. 1 Gelatin Glycerin Hypromelloses Hydrolysed Bovine Collagen (enzymatic; 2000-5000 Mw) Isopropyl Alcohol Mannitol Propylene Glycol Water Sorbitan Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L10 Shape: oval Color: blue Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2021-06-01

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
Section 42229-5

This product is not manufactured or distributed by the owners of Claritin® LIQUI-GELS®.

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.



KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DO NOT USE IF CARTON IS OPEN, OR IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA17011

www.riteaid.com

SATISFACTION

GUARANTEE

If you're not satisfied, we'll

happily refund your money.

Lot#

Expiration Date

Rev# 04/21

L0000439

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
  • Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn.
  • store between 20° to 25°C (68° to 77°F)
  • protect from freezing
Inactive Ingredients

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

Questions Or Comments?

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

Principal Display Panel

NDC 11822-2022-3

Original Prescription Strength

Compare to the active ingredient in Claritin® Liqui-Gels®*

ALLERGY RELIEF

LORATADINE CAPSULES, 10 mg

ANTIHISTAMINE

NON-DROWSY*

INDOOR/OUTDOOR ALLERGIES

24 HOUR RELIEF OF

Sneezing • Runny nose • Itchy, watery eyes

Itchy throat or nose

Actual Size

10 SOFTGELS**

(1X10) (**LIQUID-FILLED CAPSULES)

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

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.

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.


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)

This product is not manufactured or distributed by the owners of Claritin® LIQUI-GELS®.

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.



KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DO NOT USE IF CARTON IS OPEN, OR IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA17011

www.riteaid.com

SATISFACTION

GUARANTEE

If you're not satisfied, we'll

happily refund your money.

Lot#

Expiration Date

Rev# 04/21

L0000439

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)
  • Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open 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, hypromellose, hydrolyzed collagen, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments? (Questions or comments?)

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

Principal Display Panel

NDC 11822-2022-3

Original Prescription Strength

Compare to the active ingredient in Claritin® Liqui-Gels®*

ALLERGY RELIEF

LORATADINE CAPSULES, 10 mg

ANTIHISTAMINE

NON-DROWSY*

INDOOR/OUTDOOR ALLERGIES

24 HOUR RELIEF OF

Sneezing • Runny nose • Itchy, watery eyes

Itchy throat or nose

Actual Size

10 SOFTGELS**

(1X10) (**LIQUID-FILLED CAPSULES)

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

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.

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.


Advanced Ingredient Data


Raw Label Data

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