Allergy relief-D

Set ID
97997887-9cba-48f8-abcd-fdb86829459c
Manufacturer
STRATEGIC SOURCING SERVICES LLC | Sun Pharmaceutical Industries Limited
Effective date
2024-10-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:22:45

Key Label Information

Uses

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

Warnings

Warnings

Directions And Dosage

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

Other Label Information

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

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)

Products

NDC Codes

Ingredients

NameUNIIKind
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
AMMONIA5138Q19F1XIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ISOPROPYL ALCOHOLND2M416302IACT
BUTYL ALCOHOL8PJ61P6TS3IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45IACT
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Card Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/97997887-9cba-48f8-abcd-fdb86829459c/239f2cb2-b0c4-91b3-e063-6394a90a8bb7.xml
XML SHA-256
d0e55b2d33815361c3d1151f874c0e12d5649e47cf991c34d78ade0e23b663e4
XML bytes
34750

Legacy File Index

FolderFileDate
otc239f2cb2-b0c4-91b3-e063-6394a90a8bb7.xml2024-10-06
otcbb38ed64-c0f3-47f8-adec-a76c98eb921c.xml2024-10-03
otcallergy-01.jpg2023-08-17
otcbf84463e-37af-4a03-8628-7b83ee907917.xml2023-08-17