Active Ingredients
(in each extended-release tablet)
Guaifenesin USP 600 mg
Pseudoephedrine HCl USP 60 mg
Guaifenesin And Pseudoephedrine Hcl Tablet, Extended Release
FDA Label NDC 46122-801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Guaifenesin And Pseudoephedrine Hcl (NDC 46122-801). 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 active ingredients, purposes, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Expectorant
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
Warnings
- Do not use 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.
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
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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
- store at 20 to 25°C (68 to 77°F)
Inactive Ingredients
colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize).
Questions?
1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)
Distributed By
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com
Made in India
Package Label-Principal Display Panel - 600 Mg/60 Mg (18 Tablet Carton Label)
℞ GOOD *Compare to the
NEIGHBOR active ingredients in Mucinex® D
PHARMACY®
NDC 46122-801-08
12 HOUR
Mucus-D
Guaifenesin and Pseudoephedrine
Hydrochloride Extended-Release Tablets
600 mg/60 mg
Guaifenesin 600 mg - Expectorant
Pseudoephedrine HCl 60 mg - Nasal Decongestant
RELIEVES NASAL & CHEST CONGESTION
• Clears Nasal & Sinus Congestion
• Thins & Loosens Mucus
Actual size
18 Extended-Release Tablets
Package Label-principal Display Panel (600 mg/60 mg (18 Tablet Carton Label))
* Please review the disclaimer below.
