DailyMed - SUDAFED SINUS CONGESTION 12 HOUR (2024)

  • Label RSS
  • NDC Code(s): 50580-242-01, 50580-242-02, 50580-242-03
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 21, 2023

If you are a consumer or patient please visit this version.

  • Download DRUG LABEL INFO: PDF XML
  • Official Label (Printer Friendly)

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 120 mg

  • Purpose
  • 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.

    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 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).

  • 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 yearsdo 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 torn or broken
    • 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?

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

  • PRINCIPAL DISPLAY PANEL

    PREVIOUSLY SUDAFED ® 12 HOUR
    NDC 50580-242-01

    SUDAFED ®

    SINUS
    CONGESTION 12 HOUR

    Pseudoephedrine HCl Extended-Release Tablets USP, 120 mg
    Nasal Decongestant

    actual size

    MAXIMUM STRENGTH
    SINUS PRESSURE
    + CONGESTION

    10 COATED CAPLETS*
    *CAPSULE-SHAPED TABLETS

    NON-DROWSY

    DailyMed - SUDAFED SINUS CONGESTION 12 HOUR (2)

  • INGREDIENTS AND APPEARANCE
    SUDAFED SINUS CONGESTION 12 HOUR
    pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-242
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
    MAGNESIUM STEARATE (UNII: 70097M6I30)
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code SU12
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-242-011 in 1 CARTON06/17/2019
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50580-242-022 in 1 CARTON06/17/2019
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:50580-242-033 in 1 PACKAGE06/17/2019
    31 in 1 CARTON
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07515306/17/2019

    Labeler -Johnson & Johnson Consumer Inc.(878046358)

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Related Resources

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More Info on this Drug

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SUDAFED SINUS CONGESTION 12 HOUR- pseudoephedrine hydrochloride tablet, film coated, extended release

Number of versions: 3

Published Date (What is this?) Version Files
Mar 31, 2023 3 (current) download
Apr 7, 2022 2 download
Jun 17, 2019 1 download

RxNorm

SUDAFED SINUS CONGESTION 12 HOUR- pseudoephedrine hydrochloride tablet, film coated, extended release

RxCUI RxNorm NAME RxTTY
1 1049154 pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet PSN
2 1049154 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet SCD
3 1049154 pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet SY
4 1049668 SUDAFED 120 MG 12HR Extended Release Oral Tablet PSN
5 1049668 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Sudafed] SBD
6 1049668 12 HR Sudafed 120 MG Extended Release Oral Tablet SY
7 1049668 Sudafed 120 MG 12 HR Extended Release Oral Tablet SY

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SUDAFED SINUS CONGESTION 12 HOUR- pseudoephedrine hydrochloride tablet, film coated, extended release

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NDC Codes

SUDAFED SINUS CONGESTION 12 HOUR- pseudoephedrine hydrochloride tablet, film coated, extended release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1 50580-242-01
2 50580-242-02
3 50580-242-03
DailyMed - SUDAFED SINUS CONGESTION 12 HOUR (2024)

FAQs

DailyMed - SUDAFED SINUS CONGESTION 12 HOUR? ›

Take this medication by mouth with or without food, usually every 12 or 24 hours, depending on the product or as directed by your doctor or the product package. Do not take more than 240 milligrams in a day. Dosage is based on your age, medical condition, and response to treatment.

Can I take Sudafed 12-Hour every day? ›

Take this medication by mouth with or without food, usually every 12 or 24 hours, depending on the product or as directed by your doctor or the product package. Do not take more than 240 milligrams in a day. Dosage is based on your age, medical condition, and response to treatment.

What is the difference between Sudafed PE and Sudafed 12-Hour? ›

Sudafed contains pseudoephedrine, while Sudafed PE contains phenylephrine. The drugs are also available in several combinations with other over-the-counter cough and cold medications. These drugs are both nasal decongestants.

Does Sudafed 12-Hour make you sleepy? ›

Common Sudafed side effects include insomnia, headache, and anxiety or restlessness. Dry mouth, tremor, and nausea are also possible.

How long does 12 hour Sudafed stay in your system? ›

Sudafed's effects can usually be felt within 30 minutes of taking it, and they last for about 4 to 6 hours. The extended-release (ER) versions take longer to kick in (about 1 hour) but last for 12 to 24 hours. For most people, Sudafed fully exits the body within 1 to 4 days.

Why can't you use Sudafed for more than 7 days? ›

Decongestants should only be used for a short time, usually less than 7 days. If you take them for longer, you're more likely to get side effects.

Why was Sudafed taken off the market? ›

As a result of abuse of pseudoephedrine-containing products by manufacturers of methamphetamine, federal legislation was passed moving those products behind the pharmacy counter, which made them harder for people to get ahold of for routine use.

What should you not mix with Sudafed? ›

Cautions with other medicines
  • antidepressants known as monoamine oxidase inhibitors (MAOIs)
  • digoxin, a medicine for heart failure.
  • tricyclic antidepressants, such as amitriptyline.
  • ergot alkaloids, such as ergotamine (for migraine)
  • medicines for high blood pressure, such as beta blockers or methyldopa.

Which Sudafed is best for sinus pressure? ›

Sudafed PE: Everything You Need to Know. Key takeaways: Sudafed (pseudoephedrine) and Sudafed PE (phenylephrine) are decongestant medications that treat nasal and sinus congestion. Sudafed is generally more effective at relieving nasal and sinus congestion than Sudafed PE, but it has more risks.

Why should you not take Sudafed at night? ›

You should avoid taking Sudafed at night because it can cause sleep problems. To prevent this side effect, take your last dose of Sudafed several hours before you go to bed. Sudafed 24-hour tablets should be taken in the morning.

Does Sudafed dry up mucus? ›

SUDAFED® can help treat excess mucus and phlegm to make it easier and more comfortable to breathe through your nose. Our mucus relief triple action tablets contain guaifenesin, which helps to loosen the mucus in your chest.

Does Mucinex or Sudafed work better? ›

Sudafed and Mucinex are both effective at treating different cold and allergy symptoms. If you are experiencing nasal congestion and need fast relief, Sudafed may be your better option. However, if you have chest congestion and need to loosen and thin mucus, Mucinex may be the more effective choice.

Can I take Tylenol with Sudafed 12 hours? ›

Interactions between your drugs

No interactions were found between Sudafed 12-Hour and Tylenol. However, this does not necessarily mean no interactions exist. Always consult your healthcare provider.

Can I take two 12-hour Sudafed? ›

For long-acting oral dosage form (extended-release capsules or extended-release tablets): Adults and children 12 years of age and older—120 mg every 12 hours, or 240 mg every 24 hours. Do not take more than 240 mg in 24 hours. Infants and children up to 12 years of age—Use is not recommended .

Does Sudafed raise blood pressure? ›

Unfortunately, the drug doesn't affect only the head — it tightens blood vessels throughout the body. One pseudoephedrine side effect is a possible increase in blood pressure. In general, this increase is minimal in people with controlled high blood pressure.

Is it OK to take Sudafed every night? ›

It's important to limit the use of oral decongestants and only use them for up to a week without a healthcare provider's OK. Long-term use can cause side effects like high blood pressure.

What are the long term side effects of Sudafed? ›

The most commonly reported adverse effects have included cardiovascular and (e.g. elevated blood pressure, tachycardia, or arrhythmias), CNS stimulation (e.g. restlessness, insomnia, anxiety, tremors, and rarely hallucinations), skin rashes, and urinary retention.

Is Sudafed good for sinuses? ›

Each tablet contains 30 mg of pseudoephedrine HCl, a nasal decongestant that helps reduce nasal swelling and inflammation to improve ease of breathing. This non-drowsy formula provides temporary relief from sinus congestion, sinus pressure, and nasal congestion caused by the common cold or allergies.

Can you build up a tolerance to Sudafed? ›

You may develop tolerance to this medicine if you take it for a long time. Tolerance means that you will get less cough relief with time. Tell your doctor or health care professional if your symptoms do not improve or if they get worse.

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