Sinus Headache PEMaximum Strength Non-Drowsy
Acetaminophen and Phenylephrine HCl · Tablet · Oral
Active ingredient
Active ingredient (in each caplet) Acetaminophen 325 mg Phenylephrine HCl 5 mg
Purpose
Purpose Pain reliever/fever reducer Nasal decongestant
Uses
Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: sinus congestion and pressure headache minor aches and pains nasal congestion promotes sinus drainage temporarily reduces fever
Warnings
Warnings Liver warning/Allergy alert Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000mg of acetaminophen in 24 hours with other drugs containing acetminophen 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 using 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 Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dose 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 You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.
Do not use
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 using 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 Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dose 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 You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.
Ask a doctor before use
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 Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dose 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 You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dose 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 You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.
When using this product
When using this product When using this product do not exceed recommended dose 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 You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.
Stop use and ask a doctor
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 You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.
Pregnancy or breast-feeding
If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep Out of Reach of Children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Directions do not use more than directed (see overdose warning) adults and children 12 years of age and older: take 2 caplets every 4-6 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
Inactive ingredients
Inactive Ingredients corn starch, crospovidone, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide
Label text from the FDA structured product label by Allegiant Health (revised Dec 21, 2018). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 1 product
- Phenylephrine Hydrochloride in 1 product
Sinus Headache PEMaximum Strength Non-Drowsy NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 69168-270 | Acetaminophen 325 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet | Allegiant Health | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Sinus Headache PEMaximum Strength Non-Drowsy used for?
Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: sinus congestion and pressure headache minor aches and pains nasal congestion promotes sinus drainage temporarily reduces fever
Who makes Sinus Headache PEMaximum Strength Non-Drowsy?
Sinus Headache PEMaximum Strength Non-Drowsy is listed by 1 labeler in the FDA NDC directory, including Allegiant Health.