Clofera

Dosage form: liquid
Ingredients: Chlophedianol Hydrochloride 12.5mg in 5mL, Pseudoephedrine Hydrochloride 30mg in 5mL
Labeler: Centrix Pharmaceutical, Inc.
NDC Code: 11528-140

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.

Clofera

Drug Facts

Active ingredients                       Purpose
(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 12.5 mg ... Cough Suppressant
Pseudoephedrine Hydrochloride 30 mg... 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
  • nasal congestion
  • reduces swelling of 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 physician or pharmacist before taking this product.

Ask a physician 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 physician 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 ocur

If pregnant or breast feeding,

ask a health professional before use.

Keep out of the reach of children.

In case of an 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
1 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 physician

Other informationStore at 59o-86oF (15o-30oC)

Inactive ingredientsCitric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

1-866-991-9870

Manufactured for:
Centrix Pharmaceutical, Inc.
Birmingham, AL 35242

PRODUCT PACKAGING

The packaging below represents the labeling currently used.

Principal Display Panel and Side Panel for 473mL Label:

NDC 11528-140-16

Clofera

(chlophedianol HCl 12.5 mg
pseudoephedrine HCl 30 mg)

Each teaspoonful (5 mL) for oral administration contains:
Chlophedianol HCl........ 12.5 mg
Pseudoephedrine HCl..... 30 mg


Cough Suppressant/

Nasal Decongestant

Sugar Free/Alcohol Free

Dye Free/Gluten Free

16 fl oz (473 mL)

Centrix Pharmaceutical, Inc.

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.

This package not intended for dispensing to the patient.

Manufactured for:
Centrix Pharmaceutical, Inc.
Birmingham, AL 35242

Rev. 07/09


Principal Display Panel and Side Panel for 15mL Label:

NDC 11528-140-75

Clofera

(chlophedianol HCl 12.5 mg
pseudoephedrine HCl 30 mg)

Cough Suppressant
Nasal Decongestant


Each teaspoonful (5 mL) for oral administration contains:
Chlophedianol HCl....... 12.5 mg
Pseudoephedrine HCl... 30 mg

Sugar Free/Alcohol Free
Dye Free/Gluten Free

15 mL (0.5 fl oz)


See product foldout for complete prescribing information.

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.

Manufactured for:
Centrix Pharmaceutical, Inc.
Birmingham, AL 35242

Rev. 07/09


Principal Display Panel and Side Panel Panel for 118 mL Label:

NDC 11528-140-04

Clofera

(chlophedianol HCl 12.5 mg
pseudoephedrine HCl 30 mg)

Each teaspoonful (5 mL) for oral administration contains:
Chlophedianol HCl........ 12.5 mg
Pseudoephedrine HCl..... 30 mg

Cough Suppressant/
Nasal Decongestant

Sugar Free/Alcohol Free
Dye Free/Gluten 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.

Manufactured for:
Centrix Pharmaceutical Inc.
Birmingham, AL 35242      Rev. 07/09








CLOFERA 
chlophedianol hydrochloride and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11528-140
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride12.5 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride30 mg  in 5 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11528-140-753 BOTTLE (BOTTLE) in 1 CARTON
115 mL in 1 BOTTLE
2NDC:11528-140-16473 mL in 1 BOTTLE
3NDC:11528-140-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/14/2009
Labeler - Centrix Pharmaceutical, Inc. (185405367)

Revised: 11/2009
 
Centrix Pharmaceutical, 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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