Nasal Decongestant Drug Facts

Nasal Decongestant Drug Facts
SPL v1
SPL
SPL Set ID 83ae6177-afbb-477f-a5ff-64d48960ffef
Route
ORAL
Published
Effective Date 2009-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (120 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Calcium Phosphate, Dibasic, Dihydrate Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycols Polysorbate 80 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L054 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 1999-08-12
Description

Pseudoephedrine HCl 120 mg

Purpose

Nasal decongestant

Medication Information

Purpose

Nasal decongestant

Description

Pseudoephedrine HCl 120 mg

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

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.

Directions
adults and children 12 years and over
  • take 1 tablet every 12 hours
  • do not take more than 2 tablets in 24 hours
children under 12 years do not use this product in children under 12 years of age
Other Information
  • each tablet contains: calcium 45 mg
  • store at 20° - 25°C (68° - 77°F) in a dry place
  • protect from light
  • do not use if blister unit is broken or torn
  • see carton end panel for lot number and expiration date
  • this product meets the requirements of USP Drug Release Test 3
Inactive Ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions Or Comments?

1-800-719-9260

Principal Display Panel

Compare to Sudafed® 12 Hour Caplets active ingredient

Nasal Decongestant

MAXIMUM STRENGTH

NON-DROWSY

SINUS

pseudoephedrine hydrochloride extended release tablets, 120 mg

Long-Acting Nasal Decongestant

12-Hour

Sinus pressure

Congestion

Pseudoephedrine HCl

120 mg each

*(Capsule-shaped Tablets)

When Using This Product

do not exceed recommended dosage

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
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)

Active Ingredient (in Each Tablet)

Pseudoephedrine HCl 120 mg

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Structured Label Content

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

Nasal decongestant

Warnings

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.

Directions
adults and children 12 years and over
  • take 1 tablet every 12 hours
  • do not take more than 2 tablets in 24 hours
children under 12 years do not use this product in children under 12 years of age
Other Information (Other information)
  • each tablet contains: calcium 45 mg
  • store at 20° - 25°C (68° - 77°F) in a dry place
  • protect from light
  • do not use if blister unit is broken or torn
  • see carton end panel for lot number and expiration date
  • this product meets the requirements of USP Drug Release Test 3
Inactive Ingredients (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel

Compare to Sudafed® 12 Hour Caplets active ingredient

Nasal Decongestant

MAXIMUM STRENGTH

NON-DROWSY

SINUS

pseudoephedrine hydrochloride extended release tablets, 120 mg

Long-Acting Nasal Decongestant

12-Hour

Sinus pressure

Congestion

Pseudoephedrine HCl

120 mg each

*(Capsule-shaped Tablets)

When Using This Product (When using this product)

do not exceed recommended dosage

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Pseudoephedrine HCl 120 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:36.667388 · Updated: 2026-03-14T22:53:27.452907