FDA Label for Revasol Nighttime Cold And Flu

Otc - Active Ingredient

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

Otc - Purpose

Pain Reliever-Fever Reducer

Cough Suppressant

Antihistamine

Indications & 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.

Warnings

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.

Otc - Do Not Use

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

Otc - Ask Doctor

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.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - When Using

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.

Otc - Stop Use

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.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If pregnant or breast-feeding, ask a health professional before use.

Overdosage

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.

Dosage & 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

• when using Day Time and Night Time products, limit total to 4 doses per 24 hours

Other Safety Information

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 Ingredient

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.

Otc - Questions

Questions or comments 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)