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Guaifenesin and pseudoephedrine hydrochloride Extended Release

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)

Revised: 11/2016
 
REMEDYREPACK INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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