Publix Super Markets, Inc. Allergy Relief D Drug Facts

Publix Super Markets, Inc. Allergy Relief D Drug Facts
SPL v3
SPL
SPL Set ID 821c3880-303d-470a-af6a-e13be7ab313f
Route
ORAL
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (5 mg) Pseudoephedrine (120 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose, Unspecified Lactose Monohydrate Low-substituted Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L147 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2020-02-12

Description

Cetirizine HCl 5 mg Pseudoephedrine HCl 120 mg

Purpose

Antihistamine Nasal decongestant


Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Cetirizine HCl 5 mg Pseudoephedrine HCl 120 mg

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • nasal congestion
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily restores freer breathing through the nose
Directions
  • do not break or chew tablet; swallow tablet whole
  •  
    adults and children 12 years and over
  •  
    take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
  •  
    adults 65 years and over
  •  
    ask a doctor
  •  
    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 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.
Other Information
  • store between 68° to 77°F (20° to 25°C)
  • do not use if blister unit is broken or torn
  • see side panel for lot number and expiration date
  • meets USP Dissolution Test 2
Inactive Ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

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
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)

If Pregnancy Or Breast Feeding:
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
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.
Package/label Principal Display Panel

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INDOOR + OUTDOOR ALLERGIES

allergyreliefD

CETIRIZINE HYDROCHLORIDE & PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 5 mg/120 mg

ANTIHISTAMINE/NASAL DECONGESTANT

12 hour relief

ALLERGY + SINUS

NASAL CONGESTION + SINUS PRESSURE

• Sneezing

• Itchy, watery eyes

• Runny nose

• Itchy nose or throat

ACTUAL SIZE

12 EXTENDED-RELEASE TABLETS

ACTUAL SIZE

*Compare to Zyrtec-D® active ingredients

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

Active Ingredients (in Each Extended Release Tablet)

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg


Structured Label Content

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

Antihistamine

Nasal decongestant

Directions
  • do not break or chew tablet; swallow tablet whole
  •  
    adults and children 12 years and over
  •  
    take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
  •  
    adults 65 years and over
  •  
    ask a doctor
  •  
    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 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.
Other Information (Other information)
  • store between 68° to 77°F (20° to 25°C)
  • do not use if blister unit is broken or torn
  • see side panel for lot number and expiration date
  • meets USP Dissolution Test 2
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

When Using This Product (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 (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
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. (1-800-222-1222)

If Pregnancy Or Breast Feeding: (If pregnancy or breast-feeding:)
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Ask A Doctor Before Use If You Have (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.
Package/label Principal Display Panel (Package/Label Principal Display Panel)

p

INDOOR + OUTDOOR ALLERGIES

allergyreliefD

CETIRIZINE HYDROCHLORIDE & PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 5 mg/120 mg

ANTIHISTAMINE/NASAL DECONGESTANT

12 hour relief

ALLERGY + SINUS

NASAL CONGESTION + SINUS PRESSURE

• Sneezing

• Itchy, watery eyes

• Runny nose

• Itchy nose or throat

ACTUAL SIZE

12 EXTENDED-RELEASE TABLETS

ACTUAL SIZE

*Compare to Zyrtec-D® active ingredients

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives.

Active Ingredients (in Each Extended Release Tablet) (Active ingredients (in each extended release tablet))

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg


Advanced Ingredient Data


Raw Label Data

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