FDA.reportPublic FDA data

Pseudoephedrine Hydrochloride

Manufacturer
CVS Pharmacy, Inc.
Effective date
2020-11-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:06:52

Label at a glance#

ProductPseudoephedrine Hydrochloride
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves sinus congestion and pressure  temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Dosage and administration

adults and children 12 years of age and over take 2 tablets every 4 to 6 hours do not take more than 8 tablets in 24 hours children 6 to 11 years of age take 1 tablet every 4 to 6 hours  do not take more than 4 tablets in 24 hours children under 6 years of age do not use this product in children under 6 years of age

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Pseudoephedrine HCI 30 mg

OTC - PURPOSE SECTION

Purpose

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • heart disease 
  • high blood pressure
  • thyroid disease 
  • diabetes 
  • trouble urinating due to an enlarged prostate gland

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur 
  • symptoms do not improve within 7 days or occur with a fever

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over

  • take 2 tablets every 4 to 6 hours
  • do not take more than 8 tablets in 24 hours

children 6 to 11 years of age

  • take 1 tablet every 4 to 6 hours 
  • do not take more than 4 tablets in 24 hours

children under 6 years of age

  • do not use this product in children under 6 years of age

Other Information

OTHER SAFETY INFORMATION

  • store at 20ºC-25ºC (68º-77ºF)
  • do not use if blister is broken or torn

INACTIVE INGREDIENT SECTION

Calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

Important: Read all product information before using this box for important information.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Sudafed® Congestion.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy CVS.com®

1-800-SHOP CVS V-34602

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health TM

Compare to the active ingredient in Sudafed® Congestion*

Non-Drowsy

Nasal Decongestant

Pseudoephedrine Hydrochloride

Nasal decongestant

Maximum Strength

Relieves:

Nasal & sinus congestion

Sinus pressure

96 Tablets 30mg Each

1004-label-CVS1004-label-CVS

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-20469842-204-62, 69842-204-67, 69842-204-80

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHELLAC46N107B71OIACT
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
KAOLIN24H4NWX5COIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCROSEC151H8M554IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CALCIUM SULFATE ANHYDROUSE934B3V59HIACT
CARNAUBA WAXR12CBM0EIZIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM SILICATE9B9691B2N9IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b45446c3-c871-4343-e053-2995a90a898e6c409c93-c1f0-3495-e053-2991aa0a731f2020-11-17WarningsExact identifier
spl id: b45446c3-c871-4343-e053-2995a90a898e
spl set id: 6c409c93-c1f0-3495-e053-2991aa0a731f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.