Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID cc1ac1b4-cbc4-539c-e053-2a95a90a5b75
Route
ORAL
Published
Effective Date 2023-12-01
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg) Pseudoephedrine (60 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose 2208 (15000 Mpa.s) Magnesium Stearate Microcrystalline Cellulose 101 Microcrystalline Cellulose 102 Povidone K25 Povidone K90 Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: 64;X Shape: oval Color: white Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2022-05-07

Description

(in each extended-release tablet)      Guaifenesin USP 600 mg                                                                                       Pseudoephedrine HCl USP 60 mg                                                                        

Purpose

Expectorant Nasal Decongestant


Medication Information

Purpose

Expectorant Nasal Decongestant

Description

(in each extended-release tablet)      Guaifenesin USP 600 mg                                                                                       Pseudoephedrine HCl USP 60 mg                                                                        

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
Purposes

Expectorant

Nasal Decongestant

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.

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
Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.



DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100 % SATISFACTION GUARANTEED



walgeens.com

©2021 Walgreen Co.



MADE IN INDIA



Code: AP/DRUGS/04/2016

    

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)
Active Ingredients

(in each extended-release tablet)     



Guaifenesin USP 600 mg                                                                                      

Pseudoephedrine HCl USP 60 mg                                                                        

Inactive Ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize).

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).

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

NDC 0363-9946-40



Walgreens

Compare to the active

Ingredients of Mucinex®D††



Mucus

Relief D

GUAIFENESIN USP 600 mg / EXPECTORANT

PSEUDOEPHEDRINE HCl  USP 60 mg /

NASAL DECONGESTANT

EXTENDED-RELEASE TABLETS




12 Hour



• Clears nasal/sinus congestion

• Thins & loosens mucus



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
Purposes

Expectorant

Nasal Decongestant

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.

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
Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.



DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100 % SATISFACTION GUARANTEED



walgeens.com

©2021 Walgreen Co.



MADE IN INDIA



Code: AP/DRUGS/04/2016

    

Other Information (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)
Active Ingredients (Active ingredients)

(in each extended-release tablet)     



Guaifenesin USP 600 mg                                                                                      

Pseudoephedrine HCl USP 60 mg                                                                        

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize).

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Ask A Doctor Before Use If You Have (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)
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))

NDC 0363-9946-40



Walgreens

Compare to the active

Ingredients of Mucinex®D††



Mucus

Relief D

GUAIFENESIN USP 600 mg / EXPECTORANT

PSEUDOEPHEDRINE HCl  USP 60 mg /

NASAL DECONGESTANT

EXTENDED-RELEASE TABLETS




12 Hour



• Clears nasal/sinus congestion

• Thins & loosens mucus



18

EXTENDED-

RELEASE

TABLETS




Advanced Ingredient Data


Raw Label Data

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