Otc - Purpose
Active ingredients (in each extended-release tablet) | Purposes |
Guaifenesin 600 mg | Expectorant |
Pseudoephedrine HCl 60 mg | Nasal Decongestant |
Guaifenesin And Pseudoephedrine Hcl Tablet, Extended Release
FDA Label NDC 70677-1263
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Guaifenesin And Pseudoephedrine Hcl (NDC 70677-1263). 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 otc - purpose, uses, warnings, directions, other information, inactive ingredients, questions?, guaifenesin 600 mg and pseudoephedrine hcl 60 mg extended-release tablets - carton label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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)
- do not use more than directed
- 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.
When using this product
Stop use and ask a doctor if
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
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
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
Guai-pseudo-foster-thrive (Guai Pseudo Ft Spl)
* Please review the disclaimer below.
