FDA Label for Rompe Pecho CF
View Indications, Usage & Precautions
Rompe Pecho CF Product Label
The following document was submitted to the FDA by the labeler of this product Efficient Laboratories Inc. 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.
Otc - Active Ingredient
Active Ingredients:(in each teaspoonful 5 ml.) Purpose
Dextromethorphan HBr 10 mg ...................................... Cough Suppressant
Guaifenesin 100 mg ................................................................... Expectorant
Phenylephrine HCL 5 mg .................................................... Nasal Decongestant
Otc - Purpose
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Warnings
Warnings
Do not exceed recommended dosage.
Do not use
- If you are 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 your doctor or pharmacist before taking this product.
Otc - Do Not Use
Ask a doctor before use if you have
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• a persistant or chronic cough
- a cough that is accompanied by excessive phlegm (mucus)
- symptoms do not improve within 7 days or is accompanied by a fever, rash, or persistent headache. A persistent cough may be sign of a serious condition.
- nervousness, dizziness, or sleeplessness occurs
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Stop use and ask doctor if
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Shake well before use
Do not exceed more than 6 doses in any 24-hour period or as directed by a doctor.
| Age | Dose |
adults and children 12 years of age and over | 10 mL (2 tsps) every 4 hours |
| children 6 to under 12 years of age | 5 mL (1 tsp) every 4 hours |
| children under 6 years of age | consult a doctor |
Indications & Usage
Uses
- temporarily relieves cough and nasal congestion as may occur with the common cold
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.
Inactive Ingredient
Inactive Ingredients:Blue Cohosh root extract, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, glycerin, Golden Seal root extract, Honey, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract and Zinc Sulfate.
Otc - Questions
Questions or Comments?
305-805-3456 Monday - Friday 9AM to 5PM EST
www.efficientlabs.com
Distributed by
Efficient Laboratories, Inc., Miami, Fl 33166
Made in U.S.A.
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