Heb-loratadine And Pseudoephedrine Sulfate Er Tablets

Heb-loratadine And Pseudoephedrine Sulfate Er Tablets
SPL v1
SPL
SPL Set ID 36230417-8687-d9fd-e063-6394a90ac2e5
Route
ORAL
Published
Effective Date 2025-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (240 mg) Loratadine (10 mg)
Inactive Ingredients
Ferrosoferric Oxide Silicon Dioxide Calcium Phosphate, Dibasic, Anhydrous Ethylcelluloses Hypromelloses Magnesium Stearate Polyethylene Glycol, Unspecified Povidone Propylene Glycol Shellac

Identifiers & Packaging

Pill Appearance
Imprint: LPS Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2025-05-27

Description

Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg

Purpose

Antihistamine Nasal decongestant


Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• sneezing •itchy, watery eyes

• runny nose • itching of the nose or throat

• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

• reduces swelling of nasal passages

• temporarily relieves sinus congestion and pressure

• temporarily restores freer breathing through the nose

Section 42229-5

KEEP OUTER CARTON FOR COMPLETE

WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD-RESITANT AND TAMPER EVIDENT PACKAGE.

Do not use if individual blister unit is open or torn.

This product is not manufactured or distributed by the

owners of Claritin-D® 24 hour

MADE WITH PRIDE AND CARE FOR

H-E-B® , SAN ANTONIO, TX 78204

100%

GUARANTEE

promise

If you aren't completely pleased

with this product, we'll be happy to

replace it or refund your money.

You have our word on it.

PRODUCT OF INDIA

L0000918-R1024

KD/DRUGS/KTK/25/460/2001

Directions

• do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over

1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours

children under 12 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.

• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

15's Carton

Compare to CLARITIN-D® 24 HOUR active ingredients ƚ

NDC 37808-787-35

H.E.B

Allergy Relief-D

Loratadine and Pseudoephedrine Sulfate

Exrended-Release Tablets 10 mg/ 240 mg

Indoor & Outdoor Allergies

24

Hour

Non-Drowsy*

Antihistamine/Nasal Decongestant

Original Prescription Strength

15 days of Relief

Relief of:

• Nasal and Sinus Congestion Due to Colds or Allergies

• Sneexing • Runny Nose • Itchy, Watery Eyes

• Itchy Throat or Nose Due to Allergies

15 EXTENDED- RELEASE TABLETS

Other Information
  • Safety sealed: do not use if individual blister unit is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from light and store in a dry place
Inactive Ingredients

black iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, propylene glycol, shellac

Questions Or Comments?

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

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.

• symptoms do not improve within 7 days or are accompanied by a fever

• nervousness, dizziness or sleeplessness occurs

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 (1-800-222-1222) right away.

Active Ingredient (in Each Capsule)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

Ask A Doctor Before Use If You Have

• heart disease • thyroid disease

• high blood pressure • diabetes

• trouble urinating due to enlarged prostrate gland

• 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:

• sneezing •itchy, watery eyes

• runny nose • itching of the nose or throat

• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

• reduces swelling of nasal passages

• temporarily relieves sinus congestion and pressure

• temporarily restores freer breathing through the nose

Section 42229-5 (42229-5)

KEEP OUTER CARTON FOR COMPLETE

WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD-RESITANT AND TAMPER EVIDENT PACKAGE.

Do not use if individual blister unit is open or torn.

This product is not manufactured or distributed by the

owners of Claritin-D® 24 hour

MADE WITH PRIDE AND CARE FOR

H-E-B® , SAN ANTONIO, TX 78204

100%

GUARANTEE

promise

If you aren't completely pleased

with this product, we'll be happy to

replace it or refund your money.

You have our word on it.

PRODUCT OF INDIA

L0000918-R1024

KD/DRUGS/KTK/25/460/2001

Purpose

Antihistamine

Nasal decongestant

Directions

• do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over

1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours

children under 12 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.

• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

15's Carton (15's carton)

Compare to CLARITIN-D® 24 HOUR active ingredients ƚ

NDC 37808-787-35

H.E.B

Allergy Relief-D

Loratadine and Pseudoephedrine Sulfate

Exrended-Release Tablets 10 mg/ 240 mg

Indoor & Outdoor Allergies

24

Hour

Non-Drowsy*

Antihistamine/Nasal Decongestant

Original Prescription Strength

15 days of Relief

Relief of:

• Nasal and Sinus Congestion Due to Colds or Allergies

• Sneexing • Runny Nose • Itchy, Watery Eyes

• Itchy Throat or Nose Due to Allergies

15 EXTENDED- RELEASE TABLETS

Other Information (Other information)
  • Safety sealed: do not use if individual blister unit is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from light and store in a dry place
Inactive Ingredients (Inactive ingredients)

black iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, propylene glycol, shellac

Questions Or Comments? (Questions or comments?)

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

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.

• symptoms do not improve within 7 days or are accompanied by a fever

• nervousness, dizziness or sleeplessness occurs

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 (1-800-222-1222) right away.

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

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

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

• heart disease • thyroid disease

• high blood pressure • diabetes

• trouble urinating due to enlarged prostrate gland

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


Advanced Ingredient Data


Raw Label Data

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