ALLERGY RELIEF-D- loratadine and pseudoephedrine sulfate tablet, extended release

Allergy Relief-D by

Drug Labeling and Warnings

Allergy Relief-D by is a Otc medication manufactured, distributed, or labeled by HEB, Bionpharma Inc., RECIPHARM PHARMASERVICES PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

Purpose

Antihistamine

Nasal decongestant

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

Warnings

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

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.

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.

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

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)

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF-D 
loratadine and pseudoephedrine sulfate tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-787
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE SULFATE	240 mg
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	LPS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-787-07	2 in 1 CARTON	05/27/2025
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 37808-787-35	3 in 1 CARTON	05/27/2025
2		5 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA218017	05/27/2025

Labeler - HEB (007924756)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
RECIPHARM PHARMASERVICES PRIVATE LIMITED		871401927	manufacture(37808-787)