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| Product NDC Code | 58593-003 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Rompe pecho nt nt |
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| Type | Brand | ||||||
| Pharm Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 1042675 | ||||||
| Application Number | M012 | ||||||
| Labeler Name | Efficient Laboratories Inc | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: (in each 30ml doses cup) Purpose Acetaminophen 650mg ............................................................ Pain reliever/fever reducer Dextromethorphan HBr 20 mg ..................................................Cough Suppressant Doxylamine succinate 12.5 mg ................................................ Antihistamine
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions do not take more than directed (see overdose warning) Do not exceed more than 6 doses in any 24-hour period Shake well before use measure only with dosing cup provided keep dosing cup with product mL=miliiter TSP=teaspoonful this adult product is not intended for use in children under 12 years of age Age Dose adults and children 12 years of age and over 30 mL every 4 hours children under 12 years of age do not use
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients : blue cohosh root extract, citric acid, echinacea root extract, eucalyptus oil, flavor, 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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • temporarily relieves these common cold/flu symptoms: • minor aches and pains• headache• sore throat• runny nose and sneezing • cough • relieves cough to help you get to sleep • temporarily reduces fever.
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer Cough Suppressant Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Rompe Pecho NT NT Acetaminophen, Dextromethorphan HBr, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN POTASSIUM CITRATE ANHYDROUS CAULOPHYLLUM THALICTROIDES ROOT GLYCERIN ECHINACEA ANGUSTIFOLIA ROOT EUCALYPTUS OIL GINKGO BILOBA LEAF OIL GOLDENSEAL HONEY ANHYDROUS CITRIC ACID HOREHOUND MENTHOL METHYLPARABEN LICORICE MULLEIN LEAF POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN WATER ULMUS RUBRA BARK SODIUM CHLORIDE PRUNUS SEROTINA BARK ZINC SULFATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE MYRRH SUCRALOSE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.label Pack
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor or pharmacist before use if you are: Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers.
Ask a doctor before use if you have: • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • trouble urinating due to enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis,or emphysema • a sodium-restricted diet.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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 phannacist. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions,or Parkinson'sdisease),or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI,ask a doctor or pharmacist before taking this product. • to make a childsleep_
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.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.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain or cough gets worse or lasts more than 7 days • new symptoms occur •fever gets worse or lasts more than 3 days • redness or swelling is present • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product When using this product • do not use more than directed • excitability may occur, especially in children• marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API