Perrigo Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release Tablets Drug Facts

Guaifenesin and pseudoephedrine hydrochloride Extended Release by

Drug Labeling and Warnings

Guaifenesin and pseudoephedrine hydrochloride Extended Release by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE- guaifenesin, pseudoephedrine hydrochloride tablet, extended release 
REMEDYREPACK INC.

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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: 1 in 1 BLISTER PACK

OUTER PACKAGING: 18 in 1 CARTON

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

Remedy_Label

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colororange (peach) Scoreno score
ShapeOVAL (biconvex) Size18mm
FlavorImprint Code 600;Watson
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70518-0011-018 in 1 BLISTER PACK; Type 0: Not a Combination Product11/21/201608/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09107111/21/201608/13/2019
Labeler - REMEDYREPACK INC. (829572556)

Revised: 2/2020
Document Id: 81502976-6c89-0ea2-e053-2a91aa0a7a15
Set id: 6e91061b-3e87-49e0-9deb-3644394cfd93
Version: 3
Effective Time: 20200212
 
REMEDYREPACK INC.