Signature Select 44-502

Signature Select 44-502
SPL v16
SPL
SPL Set ID ccd30132-6e29-48a2-a380-7c14984fc723
Route
ORAL
Published
Effective Date 2025-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium Crospovidone, Unspecified Fd&c Yellow No. 6 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Povidone, Unspecified Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 44;502 Shape: oval Color: orange Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2005-06-23

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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

Signature

SELECT®

  Compare to

Sudafed PE® Sinus Pressure

+ Pain active Ingredients

NDC 21130-502-21

MAXIMUM STRENGTH

Sinus Relief

Acetaminophen
325 mg - Pain Reliever / Fever Reducer

Phenylephrine HCl 5 mg - Nasal Decongestant

Relieves:

• Sinus pain and headache, sinus pressure,

nasal and sinus 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., distributors of SUDAFED PE® SINUS

PRESSURE + PAIN. 50844 REV0820N50208

DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

‡1-888-723-3929

LOVE IT

OR IT'S ON US‡

Signature Select 44-502
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
  • 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.


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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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

Signature

SELECT®

  Compare to

Sudafed PE® Sinus Pressure

+ Pain active Ingredients

NDC 21130-502-21

MAXIMUM STRENGTH

Sinus Relief

Acetaminophen
325 mg - Pain Reliever / Fever Reducer

Phenylephrine HCl 5 mg - Nasal Decongestant

Relieves:

• Sinus pain and headache, sinus pressure,

nasal and sinus 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., distributors of SUDAFED PE® SINUS

PRESSURE + PAIN. 50844 REV0820N50208

DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

‡1-888-723-3929

LOVE IT

OR IT'S ON US‡

Signature Select 44-502
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)
  • 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 (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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