Sudafed 12 Hour Pressure And Pain

Dosage form: tablet, film coated, extended release
Ingredients: Naproxen sodium 220mg, Pseudoephedrine Hydrochloride 120mg
Labeler: McNeil Consumer Healthcare Div. McNeil-PPC, Inc
NDC Code: 50580-539

SUDAFED®
12 HOUR PRESSURE+PAIN

Drug Facts

Active ingredients (in each caplet)Purposes
nonsteroidal anti-inflammatory drug
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)Pain reliever/fever reducer
Pseudoephedrine HCl 120 mg, extended-releaseNasal decongestant

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

Warnings

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)

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

Other information
  • each caplet contains: sodium 20 mg
  • do not use if carton is opened or if blister unit is broken
  • store at 20-25°C (68-77°F)
  • 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?

1-888-217-2117

PRINCIPAL DISPLAY PANEL

SINUS

NDC 50580-539-16

SUDAFED®

12 HOUR PRESSURE+ PAIN

NAPROXEN SODIUM 220mg (NSAID),
PSEUDOEPHEDRINE HCl 120mg EXTENDED-RELEASE TABLETS,
PAIN RELIEVER / FEVER REDUCER, NASAL DECONGESTANT

See New Warnings
Information

HEADACHE
Naproxen
Sodium

SINUS PRESSURE
+ CONGESTION
Pseudoephedrine
HCl

16 CAPLETS*
(1 Caplet/12 Hours)

‡Actual Caplet Size
*CAPSULE-SHAPED TABLETS

NON-DROWSY

SUDAFED   12 HOUR PRESSURE AND PAIN
naproxen sodium and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-539
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Naproxen sodium (Naproxen) Naproxen sodium220 mg
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride120 mg
Inactive Ingredients
Ingredient NameStrength
silicon dioxide 
hypromelloses 
lactose monohydrate 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycol 
polysorbate 80 
povidone 
talc 
titanium dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint CodeSUDAFED
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-539-162 BLISTER PACK (BLISTER PACK) in 1 CARTON
18 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07651811/01/2010
Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 03/2011
 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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