FDA Label for Clophed
View Indications, Usage & Precautions
Clophed Product Label
The following document was submitted to the FDA by the labeler of this product Portal Pharmaceutical. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredients (in each 5 mL teaspoonful)Chlophedianol Hydrochloride 12.5 mgGuaifenesin 100 mgPhenylephrine Hydrochloride 5 mg
Otc - Purpose
Cough SuppressantExpectorantNasal 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 1-787-832-6645Serious 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 49963-630-04ClophedEach teaspoonful (5 mL) for oral administration contains:Chlophedianol HCl.....................................12.5 mgGuaifenesin...............................................100 mgPhenylephrine HCl.........................................5 mgCough Suppressant/Expectorant/Nasal DecongestantAlcohol Free/Dye Free/Gluten Free/Sugar Free4 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 PharmaceuticalMayaguez, PR 00680 Rev. 10/09
* Please review the disclaimer below.