signature select 44-615-sm

signature select 44-615-sm
SPL v10
SPL
SPL Set ID b7b1c3cc-fdf3-4e75-8c3f-2e832f09a887
Route
oral
Published
Effective Date 2025-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) guaifenesin (200 mg) phenylephrine (5 mg)
Inactive Ingredients
starch, corn crospovidone, unspecified fd&c red no. 40 aluminum lake fd&c yellow no. 6 aluminum lake magnesium stearate maltodextrin microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified silicon dioxide sodium starch glycolate type a potato stearic acid talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;615 Shape: oval Color: orange Size: 19 mm Score: 1
Marketing Status
otc monograph drug active Since 2013-06-30

Purpose

Pain reliever Expectorant Nasal decongestant

Description

Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg


Medication Information

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • with other drugs containing acetaminophen
  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.

Uses
  • temporarily relieves:
    • nasal congestion
    • headache

    • sinus congestion and pressure
    • minor aches and pains

  • temporarily promotes nasal and/or sinus drainage

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose

Pain reliever

Expectorant

Nasal decongestant

Directions
  • do not take more than directed

  • do not take more than 12 caplets in any 24-hour period

  • adults and children 12 years and over: take 2 caplets every 4 hours

  • children under 12 years: do not use

Other Information
  • each caplet contains: sodium 3 mg
  • 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, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Description

Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Principal Display Panel

COMPARE TO  

Maximum Strength Mucinex® SINUS-MAX® Severe

Congestion & Pain Active Ingredients*

NDC 21130-615-09

Signature 

Select™

Severe Sinus

Congestion & Pain

Maximum Strength

Acetaminophen       Pain Reliever

Guaifenesin               Expectorant

Phenylephrine HCl    Nasal Decongestant



• Relieves headache

• Thins and loosens mucus

• Relieves sinus congestion

ACTUAL SIZE

20 FILM COATED

     ORANGE CAPLETS

*This product is not manufactured or distributed by RB Health (US) LLC,

distributors of Maximum Strength Mucinex® SINUS-MAX® Severe

Congestion & Pain. 50844 REV0623A61509

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

1-888-723-3929

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

OUR PROMISE

QUALITY & SATISFACTION

100% GUARANTEED

OR YOUR MONEY BACK.

Signature Select 44-615
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
Questions Or Comments?

1-800-426-9391

When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur

  • fever gets worse or lasts more than 3 days

  • pain, nasal congestion, or cough gets worse or lasts more than 7 days

  • redness or swelling is present

  • new symptoms occur

  • cough comes back or occurs with rash or headache that lasts. 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 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.

Ask A Doctor Before Use If You Have
  • liver disease
  • thyroid disease
  • diabetes

  • heart disease
  • high blood pressure

  • difficulty in urination due to enlargement of the prostate gland

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • cough that occurs with too much phlegm (mucus)

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


Structured Label Content

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • with other drugs containing acetaminophen
  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.

Uses
  • temporarily relieves:
    • nasal congestion
    • headache

    • sinus congestion and pressure
    • minor aches and pains

  • temporarily promotes nasal and/or sinus drainage

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose

Pain reliever

Expectorant

Nasal decongestant

Directions
  • do not take more than directed

  • do not take more than 12 caplets in any 24-hour period

  • adults and children 12 years and over: take 2 caplets every 4 hours

  • children under 12 years: do not use

Other Information (Other information)
  • each caplet contains: sodium 3 mg
  • 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, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Principal Display Panel (Principal display panel)

COMPARE TO  

Maximum Strength Mucinex® SINUS-MAX® Severe

Congestion & Pain Active Ingredients*

NDC 21130-615-09

Signature 

Select™

Severe Sinus

Congestion & Pain

Maximum Strength

Acetaminophen       Pain Reliever

Guaifenesin               Expectorant

Phenylephrine HCl    Nasal Decongestant



• Relieves headache

• Thins and loosens mucus

• Relieves sinus congestion

ACTUAL SIZE

20 FILM COATED

     ORANGE CAPLETS

*This product is not manufactured or distributed by RB Health (US) LLC,

distributors of Maximum Strength Mucinex® SINUS-MAX® Severe

Congestion & Pain. 50844 REV0623A61509

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

1-888-723-3929

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

OUR PROMISE

QUALITY & SATISFACTION

100% GUARANTEED

OR YOUR MONEY BACK.

Signature Select 44-615
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
Questions Or Comments? (Questions or comments?)

1-800-426-9391

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

  • fever gets worse or lasts more than 3 days

  • pain, nasal congestion, or cough gets worse or lasts more than 7 days

  • redness or swelling is present

  • new symptoms occur

  • cough comes back or occurs with rash or headache that lasts. 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 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • thyroid disease
  • diabetes

  • heart disease
  • high blood pressure

  • difficulty in urination due to enlargement of the prostate gland

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • cough that occurs with too much phlegm (mucus)

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

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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