Otc - Active Ingredient
Active Ingredient (In each 5ml teaspoonful)................. Purpose
Guaifenesin 100 mg ...................................................... Expectorant
Rompe Pecho Liquid
FDA Label NDC 58593-265
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Efficient Laboratories, Inc. for the product Rompe Pecho (NDC 58593-265). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Expectorant
Indications & Usage
Uses
• Helps loosen phlegm (mucus) and thin bronchial secretions to rid the 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 accompainied by a fever, rash or persistent headache. A persistent cough may be a sign of serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of accidental overdose, get medical help or contact the Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
Directions:Shake well before use. Do not exceed 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 (2tsps) 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 |
Inactive Ingredient
Inactive Ingredients:
Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, Glycerin, 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 and Zinc Sulfate.
Otc - Questions
Questions or Comments?
305-805-3456 Monday-Friday 9AM-5PM EST
www.efficientlabs.com
Package Label.Principal Display Panel
Rompepechosflabel (Rpsfbox)
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