Version
v4
ALLERGY RELIEF-D — v4
ALLERGY RELIEF-D
7 Views
Effective date
September 23, 2025
Original packager
Yes
Sections captured
17
Identifiers
- Document ID
- 3f73940e-d14e-68fa-e063-6394a90ac6e3
- Set ID
- 0b26004d-f741-48e1-bf2b-ec4af8150160
- Application numbers
- ANDA076557
- Product NDCs
- 59779-726
- Package NDCs
- 59779-726-15, 59779-726-56, 59779-726-69
- Original packager NDCs
- —
Names & Manufacturers
- Brand names
- ALLERGY RELIEF-D
- Generic names
- LORATADINE AND PSEUDOEPHEDRINE
- Manufacturer names
- CVS Pharmacy
- Product types
- HUMAN OTC DRUG
Substances & Pharmacology
- Substance names
- LORATADINE, PSEUDOEPHEDRINE SULFATE
- Routes
- ORAL
- Pharmacologic class (PE)
- —
- Pharmacologic class (EPC)
- —
- Pharmacologic class (CS)
- —
- Mechanism of action
- —
Other identifiers
- NUI
- —
- RxCUI
- 1117562
- UNII
- 7AJO3BO7QN, Y9DL7QPE6B
- UPC
- —
Structured Label Sections
Active Ingredient (1)
Sequence 1
ACTIVE INGREDIENTS (IN EACH TABLET) Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg
Ask Doctor (1)
Sequence 1
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.
Do Not Use (1)
Sequence 1
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.
Dosage And Administration (1)
Sequence 1
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
Dosage And Administration Table (1)
Sequence 1
| 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 |
Inactive Ingredient (1)
Sequence 1
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
Indications And Usage (1)
Sequence 1
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
Keep Out Of Reach Of Children (1)
Sequence 1
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).
Package Label Principal Display Panel (1)
Sequence 1
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
Pregnancy Or Breast Feeding (1)
Sequence 1
If pregnant or breast-feeding, Ask a health professional before use.
Purpose (1)
Sequence 1
PURPOSE Antihistamine Nasal decongestant
Questions (1)
Sequence 1
QUESTIONS? Call 1-800-406-7984
Spl Product Data Elements (1)
Sequence 1
ALLERGY RELIEF-D Loratadine and Pseudoephedrine CALCIUM CARBONATE SILICON DIOXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, CORN PROPYLENE GLYCOL SHELLAC SODIUM ALGINATE SODIUM CITRATE, UNSPECIFIED FORM TALC TITANIUM DIOXIDE LORATADINE LORATADINE PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE White to Off-White RX;724
Spl Unclassified Section (1)
Sequence 1
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
Stop Use (1)
Sequence 1
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
Warnings (1)
Sequence 1
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).
When Using (1)
Sequence 1
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
OpenFDA raw payload
{'application_number': ['ANDA076557'],
'brand_name': ['ALLERGY RELIEF-D'],
'generic_name': ['LORATADINE AND PSEUDOEPHEDRINE'],
'is_original_packager': [True],
'manufacturer_name': ['CVS Pharmacy'],
'package_ndc': ['59779-726-56', '59779-726-69', '59779-726-15'],
'product_ndc': ['59779-726'],
'product_type': ['HUMAN OTC DRUG'],
'route': ['ORAL'],
'rxcui': ['1117562'],
'spl_id': ['3f73940e-d14e-68fa-e063-6394a90ac6e3'],
'spl_set_id': ['0b26004d-f741-48e1-bf2b-ec4af8150160'],
'substance_name': ['LORATADINE', 'PSEUDOEPHEDRINE SULFATE'],
'unii': ['7AJO3BO7QN', 'Y9DL7QPE6B']}