Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label NDC 69729-784-06 Rompe Tos X 6 fl oz (177 mL) Rompe Tos X Children
- PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label NDC 69729-784-06 Rompe Tos X 6 fl oz (177 mL) Rompe Tos X Children
Overview
Uses temporarily relieves these common cold/flu symptoms: sinus congestion & pressure minor aches & pains nasal congestion cough due to minor throat & bronchial irritation sore throat headache temporarily reduces fever temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Indications & Usage
Uses temporarily relieves these common cold/flu symptoms: sinus congestion & pressure minor aches & pains nasal congestion cough due to minor throat & bronchial irritation sore throat headache temporarily reduces fever temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Dosage & Administration
Directions do not take more than directed (see Overdose warning) do not take more than 6 doses in any 24 hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter tsp = teaspoonful Age Dose Children 6 to under 12 years of age 10 mL or 2 tsp provided every 4 hours Children under 6 years of age do not use
Warnings & Precautions
Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 6 doses in 24 hrs, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while 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. for children under 12 years of age 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 liver disease heart disease diabetes thyroid disease high blood pressure trouble urinating due to enlarged prostate gland persistent or chronic cough sush as smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sodium restricted diet When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs 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 recommended dose (overdose) may cause liver damaage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Purpose
Purpose Active ingredients (in each 10 mL = 2 teaspoonful) Purpose Acetaminophen 250 mg Pain reliever/fever reducer Dextromethorphan HBr 13.33 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal descongestant
Do Not Use
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. for children under 12 years of age 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.
When Using
When using this product do not exceed recommended dose (see overdose warning)
Stop Use & Ask a Doctor
Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Keep Out of Reach of Children
Keep out of reach of children.
Storage & Handling
Other information each 10 mL contains sodium 10 mg Store between 20-25°C (68-77°F) do not refrigerate keep carton for complete Drug facts
Questions
Questions? Call 616-600-5632 MON to FRI, 9 a.m. to 6 p.m. PTZ
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