FDA Label for Rompe Pecho Sf Flu
View Indications, Usage & Precautions
Rompe Pecho Sf Flu 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 5 mls tsp.) Purpose
Dextromethorphan HBr 10 mg ........................... Cough Suppressant
Brompheniramine Maleate 4 mg ................................. Antihistaminic
Phenylephrine HCl 10 mg ................................. Nasal Decongestant
Otc - Purpose
Purpose
Antihistamine
Cough Suppressant
Nasal Decongestant
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 and nasal congestion as may occur with the common cold
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 you are taking a prescription drug that 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 • 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 cough that is accompanied by excessive phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives
or tranquilizers.
When using this product • may cause drowsiness • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children.
Stop use and ask a doctor if • 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 a sign of a serious condition. • if nervousness, dizziness, or sleeplessness occur
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 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 5 mL (1 tsp) every 4 hours
children 6 to under 12 years of age 2.5 mL (1/2 tsp) every 4 hours
children under 6 years of age consult a doctor
Inactive Ingredient
Inactive Ingredients:
Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, Glycerine, Golden Seal Root extract,
Honey Flavor, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein Leaf extract, Myrrh gum extract, Potassium Citrate,
Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract, Zinc Sulfate.
Otc - Questions
Questions or Comments?
305-805-3456 Monday - Friday 9AM to 5PM EST
www.efficientlabs.com
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