SUDAFED PE PRESSURE PLUS PAIN PLUS MUCUS- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, film coated
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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SUDAFED PE ® Pressure + Pain + Mucus
Uses
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- sinus congestion and pressure
- headache
- minor aches and pains
- nasal congestion
- helps loosen phlegm (mucus) and thin bronchial secrections to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
Other information
- each caplet contains: sodium 3 mg
- store between 20-25°C (68-77°F)
- do not use if carton is opened or if blister unit is broken
Inactive ingedients
carnauba wax, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin
PRINCIPAL DISPLAY PANEL
See New Warning
SINUS
NDC 50580-680-25
SUDAFED PE®
PRESSURE+PAIN +MUCUS
For
Adults
Acetaminophen, Phenylephrine HCl, Guaifenesin
Pain Reliever/Fever Reducer, Nasal Decongestant, Expectorant
SINUS PRESSURE
+ CONGESTION
SINUS HEADACHE
CHEST
CONGESTION
24 CAPLETS
‡ Actual Pill Size
NON-DROWSY
| SUDAFED PE PRESSURE PLUS PAIN PLUS MUCUS
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, film coated |
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| Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358) |