Skip to Content

← See all Guaifenesin and pseudoephedrine hydrochloride Extended Release brands

Guaifenesin and pseudoephedrine hydrochloride Extended Release

Medically reviewed on November 21, 2016

Dosage form: tablet, extended release
Ingredients: GUAIFENESIN 600mg, PSEUDOEPHEDRINE HYDROCHLORIDE 60mg
Labeler: REMEDYREPACK INC.
NDC Code: 70518-0011

Perrigo Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release Tablets Drug Facts

Active ingredients (in each extended-release tablet)

Guaifenesin 600 mg

Pseudoephedrine HCl 60 mg

Purpose

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
  • store between 20-25 °C (68-77 °F)
  • do not use if blister unit is broken or torn

Inactive ingredients

colloidal silicon dioxide, copovidone, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Questions or comments?

1-800-719-9260

DRUG: Guaifenesin and pseudoephedrine hydrochloride Extended Release

GENERIC: Guaifenesin, pseudoephedrine hydrochloride

DOSAGE: TABLET, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-0011-0

COLOR: orange

SHAPE: OVAL

SCORE: No score

SIZE: 18 mm

IMPRINT: 600;Watson

PACKAGING: 18 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • GUAIFENESIN 600mg in 1
  • PSEUDOEPHEDRINE HYDROCHLORIDE 60mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • MAGNESIUM STEARATE
  • MALTODEXTRIN
  • POVIDONES
  • COPOVIDONE K25-31
  • HYPROMELLOSES
  • SILICON DIOXIDE
  • STEARIC ACID

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE 
guaifenesin, pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0011(NDC:45802-230)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN600 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
COPOVIDONE K25-31 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
STEARIC ACID 
Product Characteristics
Colororange (peach) Scoreno score
ShapeOVAL (biconvex) Size18mm
FlavorImprint Code600;Watson
Contains    
Packaging
#Item CodePackage Description
1NDC:70518-0011-018 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09107111/21/2016
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

← See all Guaifenesin and pseudoephedrine hydrochloride Extended Release brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide