FDA Label for Rompe Pecho EX
View Indications, Usage & Precautions
Rompe Pecho EX 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
Guaifenesin 100 mg ................................................................... Expectorant
Otc - Purpose
Purpose
Expectorant
Indications & Usage
Uses:
- Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus.
Warnings
Warnings
Do not exceed recommended dosage.
Ask a doctor before use if you have
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
Otc - Do Not Use
Stop use and ask a doctor if
- cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
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 and over 10 mL (2tsps) every 4 hrs.
children 6 to under 12 years of age 5 mL (1 tsp) every 4 hrs
children under 6 years of age consult a doctor
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
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