The following Structured Product Label (SPL) was submitted to the FDA by Efficient Laboratories Inc for the product Rompe Pecho Max (NDC 58593-005). 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 - ask doctor, ask a doctor or pharmacist before use if you are:, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients:(in each 30ml doses cup) Purpose
Acetaminophen 650mg ............................................................ Pain reliever/fever reducer
Dextromethorphan HBr 20 mg ..................................................Cough Suppressant
Guaifenesin 400 mg ................................................................. Expectorant
Purpose
Pain reliever/fever reducer
Cough Suppressant
Expectorant
Uses
• temporarily relieves these common cold/flu symptoms:
• minor aches and pains• headache• sore throat
• temporarily reduces fever.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur f you take • more than 6 doses in 24 hours, which is the maximum daily amount for this prcx:luct • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily wh le using this product.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters• rash
If a skin reaction occurs,stop use and seek medical help right away.
Sore throat warning: If sore throat is severe,persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting,consult a doctor promptly.
Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are now 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 a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
• heart disease • liver disease • 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, chronic bronchitis or emphysema• a cough that is followed by excessive phlegm (mucus).
• taking the blood thinning drug warfarin
do not use more than directed
Stop use and ask a doctor if:
• symptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash, or persistent headache
• Nervousness, dizziness or sleeplessness occurs • fever gets worse or last more than 3 days • redness or swelling is present or new symptoms occur. A persistent cough may be a sign of a serious condition.
If pregnant or breast-feeding,ask a health professional before use.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well
as for children even if you do not notice any signs or symptoms.
Directions do not take more than directed (see overdose warning)
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Inactive ingredients: blue cohosh root extract, citric acid, echinacea root extract, eucalyptus oil, ginkgo biloba leaf extract, glycerin, goldenseal root extract, honey, horehound (flower, leaf, stem) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum, potassium citrate, potassium sorbate, propylene glycol, Propylparaben, slippery elm bark extract, sodium chloride, sucralose, water, wild cherry bark extract and zinc sulfate.
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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