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

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.

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
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
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

Description

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

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

Section 55105-1

Active ingredients (in each extended-release tablet)

Purposes

Guaifenesin 600 mg

Expectorant

Pseudoephedrine HCl 60 mg

Nasal Decongestant

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

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.

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
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
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

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

Section 55105-1 (55105-1)

Active ingredients (in each extended-release tablet)

Purposes

Guaifenesin 600 mg

Expectorant

Pseudoephedrine HCl 60 mg

Nasal Decongestant

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

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