BRONCHO DILATE - ephedrine hcl guaifenesin tablet 
Contract Pharmacal Corp

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.

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Broncho-Dilate Tablets

Drug Facts

Active Ingredient

(in each tablet)
Ephedrine HCl, USP 12.5 mg
Guaifenesin, USP 200 mg

Purposes

Bronchodilator

Expectorant

Uses

  • Temporarily relieves shortness of breath, tightness of chest, and wheezing due to bronchial asthma
  • Eases breathing for asthma patients by reducing spasms of bronchial muscles
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and make coughs more productive

Warnings

Do not use

  • Unless a diagnosis of asthma has been made by a doctor
  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease)
  • For two weeks after stopping the MAOI drug
  • If you are uncertain whether your prescription drug contains an MAOI

Ask a doctor before use if you have

  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease
  • high blood pressure
  • ever been hospitalized for asthma
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

taking any prescription drugs for asthma

When using this product

some users may experience nervousness, tremor, sleeplessness, nausea and loss of appetite

Stop use and ask a doctor if

  • symptoms are not relieved within 1 hour or become worse
  • nervousness, tremor sleeplessness, nausea, and loss of appetite persist or become worse
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache, these could be signs of a serious condition.

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 Poison Control Center right away.

Directions

  • do not use more than the dosage below unless directed by a doctor
    adults and children 12 years of age and overtake 2 tablets initially, then 2 tablets every  4 hours as needed, not to exceed 12 tablets in 24 hours
    children under 12 years of ageconsult a physician

         DO NOT EXCEED RECOMMENDED DOSE

Other information

  • store at controlled 20˚ - 25˚C (68˚-77˚F)
  • intentional abuse of this product can be harmful or fatal

Inactive Ingredients

Crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Povidone and Silicon Dioxide.

*This product is not manufactured or distributed by Whitehall-Robins Healthcare, owner of the registered trademark Primatene® Tablets

Manufactured by
CONTRACT PHARMACAL CORP.
Hauppauge, NY 11788 USA
www.CPCHealth.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3bbf44a9-figure-01
BRONCHO DILATE 
ephedrine hcl guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-2529
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE12.5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorYELLOW (Pale yellow) Score2 pieces
ShapeROUNDSize9mm
FlavorImprint Code CPC;2529
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10267-2529-74 in 1 CARTON
115 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34102/13/2002
Labeler - Contract Pharmacal Corp (968334974)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp968334974MANUFACTURE

Revised: 1/2012
 
Contract Pharmacal Corp