Revasol Daytime Cold & Flu

Revasol Daytime Cold & Flu
SPL v1
SPL
SPL Set ID 2f9ddcc3-b913-f8b0-e063-6294a90a93ab
Route
ORAL
Published
Effective Date 2025-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg) Dextromethorphan (20 mg) Acetaminophen (650 mg)
Inactive Ingredients
Water Xanthan Gum Glycerin Sodium Benzoate Propylene Glycol Citric Acid Sorbitol Solution Sucralose Menthol Fd&c Yellow No. 6

Identifiers & Packaging

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

Description

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


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 more than 2 days, is accompanied

or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Indications and Usage

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.

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 4 hours
children under 12 years do not use
  • when using Day Time and Night Time products, carefully read each label to ensure correct dosing.

Description

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

Section 34088-5

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.

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

• 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.

Section 50567-7

When using this product

• do not use more than directed (see overdose warning)

• avoid alcoholic drinks.

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 • 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

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. • if you have ever

had an allergic reaction to this product or any of its ingredients.

Section 51727-6

Inactive ingredients

citric acid, FD&C Yellow #6, 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

Nasal decongestant

Section 55106-9

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

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: • minor aches and pains

• headache • sore throat • fever • nasal congestion • 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 4 hours
children under 12 years do not use
  • when using Day Time and Night Time products, carefully read each label to ensure correct dosing.

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 more than 2 days, is accompanied

or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Section 34088-5 (34088-5)

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.

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

• 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.

Section 50567-7 (50567-7)

When using this product

• do not use more than directed (see overdose warning)

• avoid alcoholic drinks.

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 • 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

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. • if you have ever

had an allergic reaction to this product or any of its ingredients.

Section 51727-6 (51727-6)

Inactive ingredients

citric acid, FD&C Yellow #6, 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

Nasal decongestant

Section 55106-9 (55106-9)

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

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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