FDA Label for Rompe Pecho Cf CF
View Indications, Usage & Precautions
Rompe Pecho Cf 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
Brompheniramine Maleate 4mg ................................................ Antihistamine
Dextromethorphan HBr 10 mg .................................................... Cough Suppressant
Otc - Purpose
Purpose
Antihistamine
Cough Suppressant
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
- glaucoma
- a cough that is accompanied by excessive phlegm (mucus)
- symptoms do not improve within 7 days, cough tends to recur, or symptoms are accompanied by a fever, rash or persistent headache. A persistent cough may be sign of a serious condition.
- nervousness, dizziness, or sleeplessness occurs
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to an enlarged prostate gland
• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• a breathing problem such as emphysema or chronic bronchitis
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
- Do not exceed more than 6 doses in any 24-hour period
- Shake well before use
- measure only with dosing cup provided
- keep dosing cup with product
- mL=miliiter TSP=teaspoonful
- this adult product is not intended for use in children under 12 years of age
- Dose
- adults and children 12 years of age and over
- 5 mL (1 teaspoonfuls) every 4 hours
- children under 6 years of age
- do not use
Age | |
Indications & Usage
Uses
- temporarily relieves runny nose, sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other upper respiratory allergies
- temporarily relieves cough from the common cold
Inactive Ingredient
Inactive Ingredients:Blue Cohosh root extract, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, glycerin, Golden Seal root extract, Honey, Horehound (flower, leaf, stem) extract, 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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