Guaifenesin And Pseudoephedrine Hydrochloride

Guaifenesin And Pseudoephedrine Hydrochloride
SPL v2
SPL
SPL Set ID 310d14be-e7ea-44b8-8b04-cffa39440d50
Route
ORAL
Published
Effective Date 2018-10-27
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 Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: xeuMnci;600 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
NDA Active Since 2017-08-01

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 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?

(1-800-406-7984)

You may also report side effects to this phone number.

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 type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, 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 600 Mg/60 Mg Tablet Blister Pack Carton

Walgreens

Compare to Mucinex® D

active ingredients††

12 HOUR

EXTENDED-RELEASE TABLETS

NDC 0363-0077-18

Mucus

Relief D

GUAIFENESIN 600 mg &

PSEUDOEPHEDRINE HCl 60 mg

EXTENDED-RELEASE TABLETS

EXPECTORANT & NASAL DECONGESTANT

12 HOUR

  • Clears nasal & sinus congestion
  • Thins & loosens mucus
  • Immediate & extended release

18

EXTENDED-RELEASE

TABLETS

ACTUAL SIZE


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 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?

(1-800-406-7984)

You may also report side effects to this phone number.

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 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, 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 600 Mg/60 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 600 mg/60 mg Tablet Blister Pack Carton)

Walgreens

Compare to Mucinex® D

active ingredients††

12 HOUR

EXTENDED-RELEASE TABLETS

NDC 0363-0077-18

Mucus

Relief D

GUAIFENESIN 600 mg &

PSEUDOEPHEDRINE HCl 60 mg

EXTENDED-RELEASE TABLETS

EXPECTORANT & NASAL DECONGESTANT

12 HOUR

  • Clears nasal & sinus congestion
  • Thins & loosens mucus
  • Immediate & extended release

18

EXTENDED-RELEASE

TABLETS

ACTUAL SIZE


Advanced Ingredient Data


Raw Label Data

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