Clophed

Dosage form: liquid
Ingredients: Chlophedianol Hydrochloride 12.5mg in 5mL, Guaifenesin 100mg in 5mL, Phenylephrine Hydrochloride 5mg in 5mL
Labeler: Portal Pharmaceutical
NDC Code: 49963-630

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.

Chlophed

Drug Facts Active ingredients                                                      
(in each 5 mL teaspoonful)
Chlophedianol Hydrochloride 12.5 mg
Guaifenesin 100 mg
Phenylephrine Hydrochloride 5 mg

Cough Suppressant
Expectorant
Nasal Decongestant

Usestemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • helps loosen phelgm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of the nasal passages

Warnings Do not exceed recommended dosage.

Do not use this product
  • 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
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  These could be signs of a serious condition.
  • new symptoms occur

If pregnant or breast-feeding,ask a health professional before use.

Keep out of the reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions Do not exceed recommended dosage.

Adults and children 12 years of age and over:
2 teaspoonfuls every 6 to 8 hours, not to exceed 8 teaspoonfuls in a 24 hour period
Children 6 to under 12 years of age:
1 teaspoonful every 6 to 8 hours, not to exceed 4 teaspoonfuls in a 24 hour period
Children under 6 years of age
Consult a doctor


Other informationStore at 59° - 86° F(15° - 30° C)

Inactive ingredientsCitric Acid, Glycerin, Orange Vanilla Flavor, propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, and Sorbitol.

Questions? Comments?Call 1-787-832-6645
Serious side effects associated with this product may be reported to this number.

Product Packaging:Packaging below represents the labeling currently used:

Principal display panel and side panel for 118 mL label:

NDC 49963-630-04

Clophed

Each teaspoonful (5 mL) for oral administration contains:
Chlophedianol HCl.....................................12.5 mg
Guaifenesin...............................................100 mg
Phenylephrine HCl.........................................5 mg

Cough Suppressant/Expectorant/Nasal Decongestant

Alcohol Free/Dye Free/Gluten Free/Sugar Free

4 fl oz (118 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Supplied in a tight, light-resistant container with a child-resistant cap.

See package insert for full prescribing information.

Manufactured for:
Portal Pharmaceutical
Mayaguez, PR  00680                                Rev. 10/09















































CLOPHED 
chlophedianol hydrochloride, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49963-630
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride12.5 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE, VANILLAImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49963-630-04118 mL in 1 BOTTLE
2NDC:49963-630-1515 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/28/2010
Labeler - Portal Pharmaceutical (831005199)

Revised: 12/2010
 
Portal Pharmaceutical

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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