Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Sinus Congestion And Pain (NDC 0536-1289). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Nasal decongestant
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, stearic acid
1-800-645-2158
Rugby®
NDC 0536-1289-35
Compare to the active
ingredients in SUDAFED PE®
PRESSURE + PAIN*
Maximum Strength
Sinus Congestion and Pain
Acetaminophen 325 mg/Phenylephrine HCl 5 mg
325 mg/5 mg
Pain Reliever/Fever Reducer
and Nasal Decongestant
Relieves
Sinus Headache, Sinus Pressure, Nasal Congestion
Non-Drowsy
Actual size
24 Caplets
Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
www.rugbylaboratories.com
*This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark SUDAFED PE® PRESSURE + PAIN.
50844 ORG041750208
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
* Please review the disclaimer below.