Guaifenesin And Pseudoephedrine Hydrochloride

Guaifenesin And Pseudoephedrine Hydrochloride
SPL v2
SPL
SPL Set ID c857bcd9-6696-40d5-93c0-65097598cd4b
Route
ORAL
Published
Effective Date 2022-04-13
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) Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: 058 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2022-04-07

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50570-1

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.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients (in each extended-release tablet) Purposes
Guaifenesin 600 mg Expectorant
Pseudoephedrine HCl 60 mg Nasal Decongestant
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 68-77°F (20-25°C)
Inactive Ingredients

carbomer homopolymer, NF; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

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.
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)
Principal Display Panel 36 Tablet Blister Pack Carton

NDC 41415-994-36

12-HOUR

mucusD

GUAIFENESIN 600 mg &

PSEUDOEPHEDRINE HCl 60 mg

EXTENDED-RELEASE TABLETS

EXPECTORANT & NASAL

DECONGESTANT

12 Hour

  • Clears Nasal/Sinus Congestion
  • Thins and Loosens Mucus
  • Immediate and Extended Release

36

EXTENDED-RELEASE

TABLETS

Compare to the active

ingredients of Mucinex® D


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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each extended-release tablet) Purposes
Guaifenesin 600 mg Expectorant
Pseudoephedrine HCl 60 mg Nasal Decongestant
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 (Other information)
  • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
  • store between 68-77°F (20-25°C)
Inactive Ingredients (Inactive ingredients)

carbomer homopolymer, NF; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

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.
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)
Principal Display Panel 36 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton)

NDC 41415-994-36

12-HOUR

mucusD

GUAIFENESIN 600 mg &

PSEUDOEPHEDRINE HCl 60 mg

EXTENDED-RELEASE TABLETS

EXPECTORANT & NASAL

DECONGESTANT

12 Hour

  • Clears Nasal/Sinus Congestion
  • Thins and Loosens Mucus
  • Immediate and Extended Release

36

EXTENDED-RELEASE

TABLETS

Compare to the active

ingredients of Mucinex® D


Advanced Ingredient Data


Raw Label Data

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