SUDAFED PE Pressure Plus Pain (acetaminophen 325 mg phenylephrine hydrochloride 5 mg) Dailymed
Generic: acetaminophen and phenylephrine hydrochloride is used for the treatment of Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular
IMPRINT: SU PE WL 89
SHAPE: oval
COLOR: orange
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Drug Facts
Otc - Active Ingredient Section
OTC - PURPOSE SECTION
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Phenylephrine HCl 5 mg Nasal decongestant
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
- promotes sinus drainage
- 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
- bulers
- rash
If a skin reaction occurs, stop use and seek medical help right away.
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product do not exceed recommended dose
OTC - STOP USE SECTION
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion 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
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed (see overdose warning)
adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 10 caplets in 24 hours
children under 12 years ask a doctor
Other Information
- store between 20-25°C (68-77°F)
- do not use if carton is opened or if buler unit is broken
Inactive Ingredients
carnauba wax, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide
Questions Or Comments?
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
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SINUS
NDC 50580-547-25
SUDAFED PE® PRESSURE +PAIN For Adults
Acetaminophen, Phenylephrine HCl Pain Reliever/Fever Reducer, Nasal Decongestant
SINUS PRESSURE + CONGESTION
SINUS HEADACHE
MAXIMUM STRENGTH
24 CAPLETS
NON-DROWSY
‡ Actual Pill Size
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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