Sudafed Sinus 12 Hour Pressure + Pain

Sudafed Sinus 12 Hour Pressure + Pain
SPL v6
SPL
SPL Set ID 305adca3-cdae-41e5-a10a-99d9dd0fe390
Route
ORAL
Published
Effective Date 2020-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg) Pseudoephedrine (120 mg)
Inactive Ingredients
Titanium Dioxide Silicon Dioxide Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Povidone, Unspecified Talc

Identifiers & Packaging

Pill Appearance
Imprint: SUDAFED Shape: oval Color: white Size: 19 mm Score: 1
Marketing Status
ANDA Active Since 2019-06-17

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

temporarily relieves these cold, sinus, and flu symptoms:

  • sinus pressure
  • minor body aches and pains
  • headache
  • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
  • fever
Section 42229-5

Drug Facts

Section 50565-1

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).

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Section 55105-1
Active ingredients (in each caplet) Purposes
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Pseudoephedrine HCl 120 mg, extended-release Nasal decongestant
Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • swallow whole; do not crush or chew
  • drink a full glass of water with each dose
adults and children 12 years and older
  • 1 caplet every 12 hours
  • do not take more than 2 caplets in 24 hours
children under 12 years
  • do not use
Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • 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.
  • in children under 12 years of age
Allergy Alert

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Other Information
  • each caplet contains: sodium 21 mg
  • FDA approved dissolution specification differs from the USP dissolution specification
  • store at 20-25°C (68-77°F)
  • do not use if blister unit is torn or broken
  • store in a dry place
Inactive Ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Questions Or Comments?

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

Principal Display Panel

NDC 50580-434-01

SUDAFED ®

SINUS



12 HOUR PRESSURE + PAIN

Naproxen Sodium 220 mg (NSAID),

Pseudoephedrine Hydrochloride 120 mg

Extended Release Tablets,

Pain Reliever/Fever Reducer, Nasal Decongestant

12 HOUR MULTI-SYMPTOM RELIEF OF:



• SINUS PRESSURE • BODY ACHES



• NASAL CONGESTION • SINUS CONGESTION



• HEADACHE

actual size

16 CAPLETS*



*CAPSULE-SHAPED TABLETS

NON-DROWSY

1 CAPLET / 12 HOURS

When Using This Product
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
Ask A Doctor Before Use If
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
Stop Use and Ask A Doctor If
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • fever gets worse or lasts more than 3 days
    • you have difficulty swallowing or the caplet feels stuck in your throat
    • you get nervous, dizzy, or sleepless
    • nasal congestion lasts more than 7 days
Heart Attack and Stroke Warning

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Ask A Doctor Or Pharmacist Before Use If You Are
  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug

Structured Label Content

Uses

temporarily relieves these cold, sinus, and flu symptoms:

  • sinus pressure
  • minor body aches and pains
  • headache
  • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
  • fever
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Section 55105-1 (55105-1)
Active ingredients (in each caplet) Purposes
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Pseudoephedrine HCl 120 mg, extended-release Nasal decongestant
Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • swallow whole; do not crush or chew
  • drink a full glass of water with each dose
adults and children 12 years and older
  • 1 caplet every 12 hours
  • do not take more than 2 caplets in 24 hours
children under 12 years
  • do not use
Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • 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.
  • in children under 12 years of age
Allergy Alert (Allergy alert)

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Other Information (Other information)
  • each caplet contains: sodium 21 mg
  • FDA approved dissolution specification differs from the USP dissolution specification
  • store at 20-25°C (68-77°F)
  • do not use if blister unit is torn or broken
  • store in a dry place
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-434-01

SUDAFED ®

SINUS



12 HOUR PRESSURE + PAIN

Naproxen Sodium 220 mg (NSAID),

Pseudoephedrine Hydrochloride 120 mg

Extended Release Tablets,

Pain Reliever/Fever Reducer, Nasal Decongestant

12 HOUR MULTI-SYMPTOM RELIEF OF:



• SINUS PRESSURE • BODY ACHES



• NASAL CONGESTION • SINUS CONGESTION



• HEADACHE

actual size

16 CAPLETS*



*CAPSULE-SHAPED TABLETS

NON-DROWSY

1 CAPLET / 12 HOURS

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning (Stomach bleeding warning)

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
Ask A Doctor Before Use If (Ask a doctor before use if)
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • fever gets worse or lasts more than 3 days
    • you have difficulty swallowing or the caplet feels stuck in your throat
    • you get nervous, dizzy, or sleepless
    • nasal congestion lasts more than 7 days
Heart Attack and Stroke Warning (Heart attack and stroke warning)

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

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