NU-COPD

Dosage form: tablet
Ingredients: Guaifenesin 400mg, Phenylephrine Hydrochloride 10mg
Labeler: CARWIN ASSOCIATES, INC
NDC Code: 15370-033

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Nu-COPD

Drug Facts

Active Ingredients: (in each tablet) Purpose
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal Decongestant

Uses

Temporarily relieves nose and chest congestion

  • provides expectorant action
  • loosens mucus
  • relieves stuffy nose
  • helps open nasal passages.

Warnings

Do not use for asthma or emergency breathing conditions.

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric/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 MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product
  • you may get drowsy
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery.
  • may cause excitability especially in children.

Stop use and ask a doctor if
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7days or are accompanied by fever.

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.

Do not exceed recommended dosage.

Directions
  • Adults and children 12 years and over:
    1 tablet every 4 to 6 hours, not to exceed 5 tablets in 24 hours, or as directed by a doctor.
  • Children 6 years to under 12 years:
    ½ tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor.
  • Not recommended for children under 6 years old.

Other information

Store at 59-86° F in a dry place.

Inactive ingredients

Magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.

Distributed by:
CarWin Associates, Inc.
Cropwell, AL 35054

Questions or comments?

1-866-525-4566

PRINCIPAL DISPLAY PANELPanel - 100 Tablet Bottle Label

NDC 15370-033-10

100 Tablets

Nu-COPD
Tablets

Guaifenesin  400 mg.
Phenylephrine HCl  10 mg.

Distributed by:

CarWin Associates, Inc.
Cropwell, AL 35054
Questions or comments?
1-866-525-4566

CARWIN
ASSOCIATES

NU-COPD 
guaifenesin and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15370-033
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin400 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
Povidone 
Cellulose, Microcrystalline 
Sodium Starch Glycolate Type A Potato 
Magnesium Stearate 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorImprint CodeC1
Contains    
Packaging
#Item CodePackage Description
1NDC:15370-033-10100 TABLET (TABLET) in 1 BOTTLE
2NDC:15370-033-051 BLISTER PACK (BLISTER PACK) in 1 BOX
25 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/15/2012
Labeler - CARWIN ASSOCIATES, INC (096485110)

Revised: 04/2012
 
CARWIN ASSOCIATES, INC

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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