The following Structured Product Label (SPL) was submitted to the FDA by Rnv Llc for the product Revasol Daytime Cold And Flu (NDC 84379-275). 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, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each 30 mL dose cup) Purpose
Acetaminophen 650mg....................................................Pain reliever-Fever reducer
Dextromethorphan HBr 20 mg.........................................Cough suppressant
Phenylephrine HCl 10 mg................................................Nasal decongestant
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
• temporarily relieves common cold/flu symptoms: • minor aches and pains
• headache • sore throat • fever • nasal congestion • cough due to minor throat and
bronchial irritation.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
• adults and children over 12 years of age take more than 4 doses (30 mL each in 24
hours, which is the maximum daily amount for this product
• taken with other drugs containing acetaminophen
• adult has 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, lasts 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. • if you have ever
had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you have
• liver disease • heart disease • high blood pressure
• diabetes • thyroid disease • trouble urinating due to an enlarged prostate gland • a cough
that occurs with too much phlegm (mucus) or a persistent or chronic cough such as occurs
with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product
• do not use more than directed (see overdose warning)
• avoid alcoholic drinks.
Stop use and ask a doctor if
• you get nervous, dizzy or sleepless • pain, nasal
congestion or cough get worse or lasts more than 5 days (children) or 7 days (adults)
• 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 the reach of children. If pregnant or breast-feeding, ask a health professional before use.
Overdose warning:
Taking more than the recommended dose (overdose) could cause
serious health problems, including liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control Center immediately.
Quick medical attention is critical for adults as well as for children even if you do not
notice any signs or symptoms.
Directions
• take only as directed (see overdose warning)
• measure only with dosing cup provided and keep dosage cup with product
• mL=mililiter
• do not exceed 4 doses per 24 hours
| Age | Dose |
| adults and children 12 years of and over | 30 mL every 4 hours |
| children under 12 years | do not use |
Other information
•
Each 30 mL dose cup contains: sodium 10 mg
• store at room temperature 15-30°C (59-86°F) and do not refrigerate
TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing.
Inactive ingredients
citric acid, FD&C Yellow #6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
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