Rompe Pecho Liquid
FDA Label NDC 58593-225

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 58593-225). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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Rompepechosfflabel (Rpsfflubox)

Rompepechosfflabel (Rpsfflubox)

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