Sudafed 12 Hour Pressure And Pain

Sudafed 12 Hour Pressure And Pain

Sudafed 12 Hour Pressure And Pain Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.

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
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
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, or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have
    • asthma
    • diabetes
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
  • under a doctor's care for any serious condition
  • taking any other drug
When using this product
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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
  • 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

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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
  • 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
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, or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have
    • asthma
    • diabetes
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
  • under a doctor's care for any serious condition
  • taking any other drug
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
  • 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

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Sudafed 12 Hour Pressure And Pain Manufacturers


  • Mcneil Consumer Healthcare Div. Mcneil-ppc, Inc
    Sudafed 12 Hour Pressure And Pain (Naproxen Sodium And Pseudoephedrine Hydrochloride) Tablet, Film Coated, Extended Release [Mcneil Consumer Healthcare Div. Mcneil-ppc, Inc]

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