SUDAFED Sinus Congestion

Pseudoephedrine Hydrochloride · Tablet, Film Coated · Oral

Over the counter alpha-Adrenergic Agonist

Active ingredient

Active ingredient (in each tablet) Pseudoephedrine HCl 30 mg

Purpose

Purpose Nasal decongestant

Uses

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

Warnings

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. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dose 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)

Do not use

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.

Ask a doctor before use

Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland

When using this product

When using this product do not exceed recommended dose

Stop use and ask a doctor

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever

Pregnancy 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)

Directions

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

Other information

Other information store between 20 - 25°C (68 - 77°F) do not use if blister unit is torn or broken see side panel for lot number and expiration date

Inactive ingredients

Inactive ingredients carnauba wax, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

Questions?

Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

Label text from the FDA structured product label by Kenvue Brands LLC (revised Nov 8, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

SUDAFED Sinus Congestion NDC products (1)

NDCStrength & formLabelerType
50580-363Pseudoephedrine Hydrochloride 30 mg/1
Tablet, Film Coated
Kenvue Brands LLCOTC MONOGRAPH DRUG

Frequently asked questions

What is SUDAFED Sinus Congestion used for?

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

Who makes SUDAFED Sinus Congestion?

SUDAFED Sinus Congestion is listed by 1 labeler in the FDA NDC directory, including Kenvue Brands LLC.