CLOPHED- chlophedianol hydrochloride, guaifenesin, phenylephrine hydrochloride liquid

Clophed by

Drug Labeling and Warnings

Clophed by is a Otc medication manufactured, distributed, or labeled by Portal Pharmaceutical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• 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 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

INGREDIENTS AND APPEARANCE

CLOPHED 
chlophedianol hydrochloride, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49963-630
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlophedianol Hydrochloride (UNII: 69QQ58998Y) (Chlophedianol - UNII:42C50P12AP)	Chlophedianol Hydrochloride	12.5 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	ORANGE, VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49963-630-04	118 mL in 1 BOTTLE
2	NDC: 49963-630-15	15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/28/2010

Labeler - Portal Pharmaceutical (831005199)