FDA Label for Nasal Decongestant Pe And Pain Relief Maximum Strength
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH CAPLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
Nasal Decongestant Pe And Pain Relief Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Nasal decongestant
Uses
- temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
- minor aches and pains
- nasal congestion
- headache
- sinus congestion and pressure
- 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) 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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
- diabetes
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
When Using This Product
do not exceed recommended dosage.
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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
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.
Directions
- 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
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silica gel, stearic acid
Questions?
Call 800-824-1706 Monday - Friday 9am - 4pm MST
Principal Display Panel
WinCo®
FOODS
MAXIMUM STRENGTH
Nasal
Decongestant PE
& Pain Relief
*Compare to the active ingredients in SUDAFED PE® Pressure + Pain
Non-Drowsy
Relives: Sinus Headache,
Sinus Pressure
& Nasal Congestion
ACETAMINOPHEN/
PAIN RELIEVER - FEVER REDUCER
PHENYLEPHRINE HCl/NASAL DECONGESTANT
24
Caplets
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
100% SATISFACTION GUARANTEE
Comments & Questions? 800-824-1706
* Please review the disclaimer below.