Nasal Decongestant PE and Pain Relief Maximum Strength
Medically reviewed on March 17, 2017.
Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: WinCo Foods, LLC
NDC Code: 67091-209
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.
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
- temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
- minor aches and pains
- nasal congestion
- sinus congestion and pressure
- promotes sinus drainage
- temporarily reduces fever
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) 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
If a skin reaction occurs, stop use and seek medical help right away.
- 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
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
- 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.
ask a health professional before use.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
do not use more than directed
- 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
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silica gel, stearic acid
Call 800-824-1706 Monday - Friday 9am - 4pm MST
& Pain Relief
*Compare to the active ingredients in SUDAFED PE® Pressure + Pain
Relives: Sinus Headache,
& Nasal Congestion
PAIN RELIEVER - FEVER REDUCER
PHENYLEPHRINE HCl/NASAL DECONGESTANT
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704
*This product is not manufactured or distributed by MCNEIL CONSUMER HEALTHCARE, distributor of SUDAFED PE® Pressure + Pain.
50844 REV0915A50208 WF1612
|NASAL DECONGESTANT PE AND PAIN RELIEF
acetaminophen, phenylephrine hcl tablet
|Labeler - WinCo Foods, LLC (056098817)|
|LNK International, Inc.||038154464||PACK(67091-209)|
|LNK International, Inc.||832867894||MANUFACTURE(67091-209)|
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.