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.
Active ingredients Purpose
(in each 5 mL teaspoonful)
Chlophedianol Hydrochloride 12.5 mg ... Cough Suppressant
Pseudoephedrine Hydrochloride 30 mg... Nasal Decongestant
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
Do not exceed recommended dosage.
- 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.
- 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
- 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
ask a health professional before use.
In case of an accidental overdose, seek professional help or contact a Poison Control Center immediately.
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 |
1-866-991-9870
Manufactured for:
Centrix Pharmaceutical, Inc.
Birmingham, AL 35242
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 |
|||||||||||||||||||
|
|||||||||||||||||||
|
|||||||||||||||||||
|
|||||||||||||||||||
|
|||||||||||||||||||
|
|||||||||||||||||||
| Labeler - Centrix Pharmaceutical, Inc. (185405367) |
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
