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ALLERGY RELIEF-D

Drug Facts

Approved
Approval ID

0b26004d-f741-48e1-bf2b-ec4af8150160

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

CVS Pharmacy

DUNS: 062312574

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Loratadine and Pseudoephedrine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59779-726
Application NumberANDA076557
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loratadine and Pseudoephedrine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (19)

CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LORATADINEActive
Quantity: 10 mg in 1 1
Code: 7AJO3BO7QN
Classification: ACTIB
PSEUDOEPHEDRINE SULFATEActive
Quantity: 240 mg in 1 1
Code: Y9DL7QPE6B
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/13/2019

PRINCIPAL DISPLAY PANEL - 5 Tablet Blister Pack Carton

CVSHealth ™

Compare to the active
ingredients in Claritin-D ®24 Hour †

Indoor & Outdoor Allergies

Original Prescription Strength

Non-Drowsy*

Allergy Relief-D
24
HOUR

PSEUDOEPHEDRINE SULFATE, USP 240 mg
Nasal decongestant
LORATADINE, USP 10 mg
Antihistamine

24 Hour Relief of:

  • Nasal & sinus congestion due to colds or allergies
  • Sneezing; Runny nose; Itchy, watery eyes;
    Itchy throat or nose due to allergies

5 EXTENDED
RELEASE TABLETS

Actual Size

*When taken as directed.
See Drug Facts Panel.

PRINCIPAL DISPLAY PANEL - 5 Tablet Blister Pack Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/13/2019

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
  • reduces swelling of nasal passages

  • temporarily relieves sinus congestion and pressure

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

  • temporarily restores freer breathing through the nose

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/13/2019

ACTIVE INGREDIENTS (IN EACH TABLET)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/13/2019

PURPOSE

Antihistamine

Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 12/13/2019

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 an enlarged prostate 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 right away (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/13/2019

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 12/13/2019

OTHER INFORMATION

***sodium:**contains 10 mg/tablet ***calcium:**contains 25 mg/tablet *TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

  • store between 20° C to 25° C (68° F to 77° F)
  • protect from light and store in a dry place

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/13/2019

INACTIVE INGREDIENTS

Calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 12/13/2019

QUESTIONS?

Call1-800-406-7984

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