Revasol Nighttime Cold&flu
30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
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
Medication Information
Warnings and Precautions
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.
Indications and Usage
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.
Dosage and Administration
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
Description
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
Section 34088-5
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.
Section 50565-1
Keep out of the reach of children. If pregnant or breast-feeding, ask a health professional before use.
Section 50566-9
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.
Section 50567-7
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.
Section 50568-5
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Section 50569-3
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.
Section 50570-1
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
Section 51727-6
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.
Section 51945-4
Section 53413-1
Questions or comments 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)
Section 55105-1
Pain Reliever-Fever Reducer
Cough Suppressant
Antihistamine
Section 55106-9
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
Section 60561-8
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.
Structured Label Content
Indications and Usage (34067-9)
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.
Dosage and Administration (34068-7)
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
Warnings and Precautions (34071-1)
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.
Section 34088-5 (34088-5)
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.
Section 50565-1 (50565-1)
Keep out of the reach of children. If pregnant or breast-feeding, ask a health professional before use.
Section 50566-9 (50566-9)
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.
Section 50567-7 (50567-7)
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.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Section 50569-3 (50569-3)
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.
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
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.
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions or comments 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)
Section 55105-1 (55105-1)
Pain Reliever-Fever Reducer
Cough Suppressant
Antihistamine
Section 55106-9 (55106-9)
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
Section 60561-8 (60561-8)
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.
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Raw Label Data
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Source: dailymed · Ingested: 2026-02-15T12:05:46.897493 · Updated: 2026-03-14T23:08:04.646392