Guaifenesin And Pseudoephedrine Hcl Tablet, Extended Release
FDA Label NDC 30142-137

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Guaifenesin And Pseudoephedrine Hcl (NDC 30142-137). 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

Active Ingredients

(in each extended-release tablet)     

Guaifenesin USP 600 mg                                                                                      

Pseudoephedrine HCl USP 60 mg                                                                        

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 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 tablets every 12 hours; not more than 4 tablets in 24 hours
  • children under 12 years of age: do not use

Other Information

  • tamper evident: do not use if carton is opened or if individual blister units are torn or opened.
  • 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?

1-800-632-6900 You may also report side effects to this phone number.


DISTRIBUTED BY
THE KROGER CO.
CINCINNATI, OHIO 45202

MADE IN INDIA

Code: AP/DRUGS/04/2016

Package Label-Principal Display Panel - 600 Mg/60 Mg (18 Tablet Carton Label)

COMPARE TO the active ingredients of
MUCINEX® D *See back panel                        NDC 30142-137-12
Kroger®

Mucus-D
Guaifenesin and
Pseudoephedrine
Hydrochloride
Extended-Release
Tablets 600 mg/60 mg

EXPECTORANT &
NASAL
DECONGESTANT

12
HOUR

Clears Nasal/
Sinus Congestion
Thins and Loosens Mucus

actual
size

18 EXTENDED-RELEASE
TABLETS

Package Label-principal Display Panel (600 mg/60 mg (18 Tablet Carton Label))

Package Label-principal Display Panel (600 mg/60 mg (18 Tablet Carton Label))

* Please review the disclaimer below.