Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 27f85134-cd38-b33c-e063-6394a90a05a8
Route
ORAL
Published
Effective Date 2021-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg) Pseudoephedrine (60 mg)
Inactive Ingredients
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Magnesium Stearate Hypromellose 2910 (10000 Mpa.s) Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: 058 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2024-12-13

Description

Active ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg Nasal Decongestant


Medication Information

Description

Active ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg Nasal Decongestant

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure
Section 55105-1

Active ingredients (in each extended-release tablet)

Purposes

Guaifenesin 600 mg

Expectorant

Pseudoephedrine HCl 60 mg

Nasal Decongestant

Warnings

Do not useif 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.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

When using this product

  • do not use more than directed

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • do not crush, chew, or break extended-release tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
  • children under 12 years of age: do not use
Questions?

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

Keep the carton. It contains important information.

See end panel for expiration date.

*All trademarks are property of their respective owners. This product is not affliated with the makers/owners of Mucinex® D.



©2023 McKesson Corporation



Distributed by: McKesson Corp.,

via Strategic Sourcing Services LLC.

Memphis, TN 38141

Money Back Guarantee

www.fosterandthrive.com

Rev. 11/2024

Other Information
  • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
  • store between 20-25°C (68-77°F)
Inactive Ingredients

carbomer homopolymer, NF; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

Guaifenesin 600 Mg and Pseudoephedrine Hcl 60 Mg Extended Release Tablets Carton Label

NDC 70677-1263-1

COMPARE TO THE ACTIVE

INGREDIENTS OF MUCINEX ®D

Foster & Thrive TM

12 HOUR

Mucus Relief D

Guaifenesin 600 mg & Pseudoephedrine HCl 60 mg

Extended-Release Tablets

EXPECTORANT & NASAL DECONGESTANT

  • Clears Nasal/Sinus Congestion
  • Thins and Loosens Mucus
  • Immediate and Extended Release

ACTUAL SIZE

18 EXTENDED-RELEASE TABLETS


Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure
Section 55105-1 (55105-1)

Active ingredients (in each extended-release tablet)

Purposes

Guaifenesin 600 mg

Expectorant

Pseudoephedrine HCl 60 mg

Nasal Decongestant

Warnings

Do not useif 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.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

When using this product

  • do not use more than directed

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • do not crush, chew, or break extended-release tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
  • children under 12 years of age: do not use
Questions?

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

Keep the carton. It contains important information.

See end panel for expiration date.

*All trademarks are property of their respective owners. This product is not affliated with the makers/owners of Mucinex® D.



©2023 McKesson Corporation



Distributed by: McKesson Corp.,

via Strategic Sourcing Services LLC.

Memphis, TN 38141

Money Back Guarantee

www.fosterandthrive.com

Rev. 11/2024

Other Information
  • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
  • store between 20-25°C (68-77°F)
Inactive Ingredients

carbomer homopolymer, NF; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

Guaifenesin 600 Mg and Pseudoephedrine Hcl 60 Mg Extended Release Tablets Carton Label (Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg Extended-Release Tablets - Carton Label)

NDC 70677-1263-1

COMPARE TO THE ACTIVE

INGREDIENTS OF MUCINEX ®D

Foster & Thrive TM

12 HOUR

Mucus Relief D

Guaifenesin 600 mg & Pseudoephedrine HCl 60 mg

Extended-Release Tablets

EXPECTORANT & NASAL DECONGESTANT

  • Clears Nasal/Sinus Congestion
  • Thins and Loosens Mucus
  • Immediate and Extended Release

ACTUAL SIZE

18 EXTENDED-RELEASE TABLETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)