CLOPHED - chlophedianol hydrochloride, guaifenesin, phenylephrine hydrochloride liquid 
Portal Pharmaceutical

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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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

Uses

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

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 information

Store at 59° - 86° F(15° - 30° C)

Inactive ingredients

Citric 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 Packaging



Clophed Packaging






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CLOPHED 
chlophedianol hydrochloride, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49963-630
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (UNII: 69QQ58998Y) (Chlophedianol - UNII:42C50P12AP) Chlophedianol Hydrochloride12.5 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid (UNII: 2968PHW8QP)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sorbitol (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE, VANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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
Document Id: 11108f5d-d9ea-498e-ba87-a6eff07dfa7f
Set id: 49370e61-f9db-47d0-a43f-b1797b077867
Version: 2
Effective Time: 20101230
 
Portal Pharmaceutical