Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 19cde6f8-649a-df69-7ee9-05da2cccba5b
Route
ORAL
Published
Effective Date 2017-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg) Pseudoephedrine (120 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Hypromelloses Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Povidone Silicon Dioxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2019-07-08

Description

Guaifenesin USP, 1200 mg................................................................................Expectorant Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant  

Purpose

Expectorant and Nasal Decongestant


Medication Information

Purpose

Expectorant and Nasal Decongestant

Description

Guaifenesin USP, 1200 mg................................................................................Expectorant Pseudoephedrine HCl USP, 120 mg......................................................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

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: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use
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.

Questions?

call 1-888-375-3784

You may also report side effect 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

FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.

Principal Display Panel

Guaifenesin and Pseudoephedrine HCl ER Tablets 1200 mg/120 mg:

When Using This Product
  • do not use more than directed
Stop Use and Ask 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)

Active Ingredients (in Each Extended Release Tablet)

Guaifenesin USP, 1200 mg................................................................................Expectorant

Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant 


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
Purpose

Expectorant and Nasal Decongestant

Warnings

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: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use
Do Not Use (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.

Questions?

call 1-888-375-3784

You may also report side effect 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)

FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.

Principal Display Panel

Guaifenesin and Pseudoephedrine HCl ER Tablets 1200 mg/120 mg:

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask Doctor If (Stop use and ask 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)

Active Ingredients (in Each Extended Release Tablet) (Active ingredients (in each extended-release tablet))

Guaifenesin USP, 1200 mg................................................................................Expectorant

Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant 


Advanced Ingredient Data


Raw Label Data

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