Rugby 44-502
fc42e97d-1224-4d29-a55d-1a1885e0bf8f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325 mg Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer Nasal decongestant
Medication Information
Purpose
Pain reliever/fever reducer
Nasal decongestant
Description
Acetaminophen 325 mg Phenylephrine HCl 5 mg
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. 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.
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
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
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, silicon dioxide, stearic acid
Questions Or Comments?
1-800-426-9391
Principal Display Panel
Rugby®
NDC 0536-1289-35
compare to the active ingredients in
Sudafed PE® Sinus Pressure + Pain*
maximum strength
sinus congestion & pain
acetaminophen 325 mg
pain reliever/fever reducer
phenylephrine HCl 5 mg
nasal decongestant
relieves: sinus headache, sinus pressure
and nasal congestion
non-drowsy
actual size
24 caplets
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Kenvue Inc., owner
of the registered trademark SUDAFED PE® SINUS PRESSURE + PAIN.
50844 REV0820B50208
Rev. 04/25 R-17 Re-order No. 371023
Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com
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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredients (in Each Caplet)
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Ask A Doctor Before Use If You Have
- heart disease
- thyroid disease
- diabetes
- liver 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.
Structured Label Content
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
Purpose
Pain reliever/fever reducer
Nasal decongestant
Warnings
Liver warning: This product contains acetaminophen. 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.
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
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 taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
Other Information (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 (Inactive ingredients)
corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, stearic acid
Questions Or Comments? (Questions or comments?)
1-800-426-9391
Principal Display Panel (Principal display panel)
Rugby®
NDC 0536-1289-35
compare to the active ingredients in
Sudafed PE® Sinus Pressure + Pain*
maximum strength
sinus congestion & pain
acetaminophen 325 mg
pain reliever/fever reducer
phenylephrine HCl 5 mg
nasal decongestant
relieves: sinus headache, sinus pressure
and nasal congestion
non-drowsy
actual size
24 caplets
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Kenvue Inc., owner
of the registered trademark SUDAFED PE® SINUS PRESSURE + PAIN.
50844 REV0820B50208
Rev. 04/25 R-17 Re-order No. 371023
Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com
When Using This Product (When using this product)
do not exceed recommended dosage.
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)
ask a health professional before use.
Keep Out of Reach of Children. (Keep out of reach of children.)
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- heart disease
- thyroid disease
- diabetes
- liver disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
taking the blood thinning drug warfarin.
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Source: dailymed · Ingested: 2026-02-15T12:06:26.873602 · Updated: 2026-03-14T23:09:13.832086