Rugby 44-453 Delisted
953cad64-d587-4f25-a04f-fee2edf9ebb2
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Phenylephrine HCl 10 mg
Purpose
Nasal decongestant
Medication Information
Purpose
Nasal decongestant
Description
Phenylephrine HCl 10 mg
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
Directions
- adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
- children under 12 years: ask a doctor
Do Not Use
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.
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
croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide
Questions Or Comments?
1-800-645-2158
Principal Display Panel
Rugby®
NDC 0536-1291-36
Compare to the
active ingredient in
SUDAFED PE®
SINUS CONGESTION*
Maximum Strength
Phenylephrine HCl
10 mg
Nasal Decongestant
Sinus Pressure, Sinus and Nasal Congestion
Non-Drowsy
Actual Size
36 Tablets
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 Johnson & Johnson
Corporation, owner of the registered trademark SUDAFED PE® SINUS
CONGESTION. 50844 REV0820A45307
Rev. 01/21 R-17 Re-order No. 371024
Distributed by: RUGBY® LABORATORIES
Livonia, MI 48152
www.rugbylaboratories.com
When Using This Product
do not exceed recommended dosage.
Stop Use and Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with fever
If Pregnant Or Breast Feeding,
ask a health professional before use.
Keep Out of Reach of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Active Ingredient (in Each Tablet)
Phenylephrine HCl 10 mg
Ask A Doctor Before Use If You Have
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
Structured Label Content
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
Purpose
Nasal decongestant
Directions
- adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
- children under 12 years: ask a doctor
Do Not Use (Do not use)
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.
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)
croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide
Questions Or Comments? (Questions or comments?)
1-800-645-2158
Principal Display Panel (Principal display panel)
Rugby®
NDC 0536-1291-36
Compare to the
active ingredient in
SUDAFED PE®
SINUS CONGESTION*
Maximum Strength
Phenylephrine HCl
10 mg
Nasal Decongestant
Sinus Pressure, Sinus and Nasal Congestion
Non-Drowsy
Actual Size
36 Tablets
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 Johnson & Johnson
Corporation, owner of the registered trademark SUDAFED PE® SINUS
CONGESTION. 50844 REV0820A45307
Rev. 01/21 R-17 Re-order No. 371024
Distributed by: RUGBY® LABORATORIES
Livonia, MI 48152
www.rugbylaboratories.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
- symptoms do not improve within 7 days or occur with fever
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 overdose, get medical help or contact a Poison Control Center right away.
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))
Phenylephrine HCl 10 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:41.669665 · Updated: 2026-03-14T23:09:36.432892