Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID c9fbadd0-d623-3c1f-e053-2995a90a6247
Route
ORAL
Published
Effective Date 2021-08-20
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 2021-08-20

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

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN, OR IF FOIL INNER SEAL ON BOTTLE IS BROKEN

KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Distributed by: Discount Drug Mart

211 Commerce Drive, Medina, Ohio 44256

www.discount-drugmart.com

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE

TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO

STORE, SEND REASON FOR DISSATISFACTION, NAME,

ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG

MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

R0721



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

DISCOUNT

drug

mart

FOOD MARKET

AN EMPLOYEE OWNERSHIP COMPANY

Non-Drowsy*

NDC 53943-116-13

24 Hour

Allergy Relief

Loratadine Capsules, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose

Compare to the active ingredient in Claritin ® LIQUI-GELS ®

30

SOFTGELS**

(**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)

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN, OR IF FOIL INNER SEAL ON BOTTLE IS BROKEN

KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Distributed by: Discount Drug Mart

211 Commerce Drive, Medina, Ohio 44256

www.discount-drugmart.com

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE

TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO

STORE, SEND REASON FOR DISSATISFACTION, NAME,

ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG

MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

R0721



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

DISCOUNT

drug

mart

FOOD MARKET

AN EMPLOYEE OWNERSHIP COMPANY

Non-Drowsy*

NDC 53943-116-13

24 Hour

Allergy Relief

Loratadine Capsules, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose

Compare to the active ingredient in Claritin ® LIQUI-GELS ®

30

SOFTGELS**

(**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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