The following Structured Product Label (SPL) was submitted to the FDA by Rnv Llc for the product Revasol Nighttime Cold And Flu (NDC 84379-276). 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 650 mg................................................Pain Reliever-Fever Reducer
Dextromethorphan HBr 30 mg......................................Cough Suppressant
Doxylamine Succinate 12.5mg......................................Antihistamine
Pain Reliever-Fever Reducer
Cough Suppressant
Antihistamine
Uses
• temporarily relieves common cold/flu symptoms: • sore throat • minor aches and
pains • runny nose and sneezing • headache • fever • 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 mroe than 2 days, is accompanied
or followed by fever, heacache, 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. • to make a child
sleepy
Ask a doctor before use if you have • liver disease • glaucoma • cough that occurs with
too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occur
with smoking, asthma, chronic bronchitis or emphysema • trouble urinating due to an
enlarged prostate gland.
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 • avoid alcoholic drinks • excitability may occur, especially in children • marked drowsiness may occur • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness.
Stop use and ask a doctor if
• pain 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 the reach of children. If pregnant or breast-feeding, ask a health professional before use.
Overdose warning:
Taking mroe 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 6 hours |
| children under 12 years | do not use |
• when using Day Time and Night Time products, limit total to 4 doses per 24 hours
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 Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
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