Allergy Relief-d Tablet, Film Coated, Extended Release
FDA Label NDC 70677-1020

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Allergy Relief-d (NDC 70677-1020). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Distributed by: McKesson Corp., via Strategic
Sourcing Services LLC. Memphis, TN 38141

Otc - Purpose

Active ingredients (in each extended-release tablet)Purposes
Cetirizine HCl, USP 5 mgAntihistamine
Pseudoephedrine HCl, USP 120 mgNasal decongestant

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of nose or throat
    • nasal congestion
    • reduces swelling of nasal passages
    • temporarily relieves sinus congestion and pressure
    • temporarily restores freer breathing through the nose

Do Not Use

  • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
  • 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
  • diabetes
  • glaucoma
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • liver or kidney disease. Your doctor should determine if you need a different dose.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When Using This Product

  • do not use more than directed
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • an allergic reaction to this product occurs. Seek medical help right away.
  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever

If Pregnant Or Breast-Feeding

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

Otc - 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 at 1-800-222-1222.

Directions

  • do not break or chew tablet; swallow tablet whole
  • adults and children 12 years and overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
    adults 65 years and overask a doctor
    children under 12 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

Other Information

  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened or if the blister unit is broken
  • see side panel for batch number and expiration date

Inactive Ingredients

hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide

Imprinting Ink Contents

ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze

Questions?

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

Principal Display Panel - 24 Tablet Blister Card Carton

NDC 70677-1020-1

COMPARE TO ZYRTEC-D®
12 HR ACTIVE INGREDIENTS*

Foster & Thrive™

ORIGINAL PRESCRIPTION STRENGTH

All Day Allergy-D

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Extended-release Tablets, USP 5 mg/120 mg
ANTIHISTAMINE/NASAL DECONGESTANT

Indoor & Outdoor Allergies | Allergy & Sinus

12 hour relief of:

• Sneezing       • Itchy, Watery Eyes       • Sinus Pressure
• Runny Nose  • Itchy Throat or Nose    • Nasal Congestion

ACTUAL SIZE

24 TABLETS (4 blister cards of 6 tablets each)

Principal Display Panel (24 Tablet Blister Card Carton)

Principal Display Panel (24 Tablet Blister Card Carton)

* Please review the disclaimer below.