Revasol Nighttime Cold&flu

Revasol Nighttime Cold&flu
SPL v1
SPL
SPL Set ID 30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9
Route
ORAL
Published
Effective Date 2025-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Propylene Glycol Sodium Benzoate Xanthan Gum Glycerin Fd&c Blue No. 1 Water Fd&c Red No. 40 Sucralose Menthol Anhydrous Citric Acid Sorbitol Solution 70%

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-03

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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