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
12 HOUR PRESSURE+PAIN
Drug Facts
| Active ingredients (in each caplet) | Purposes |
|---|---|
|
|
| Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) | Pain reliever/fever reducer |
| Pseudoephedrine HCl 120 mg, extended-release | Nasal decongestant |
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
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.
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
- 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
- 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
- under a doctor's care for any serious condition
- taking any other drug
- 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
- 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 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 |
|
| children under 12 years |
|
- 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
colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
1-888-217-2117
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 |
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| Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358) |
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.



