FDA Label for Nighttime Cold And Flu

Drug Facts

Active ingredients (in each 30 mL dose cup) 

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Purpose

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.

• if you have ever had an allergic reaction to this product or anay of its ingredients

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 sedatives or tranquilizers
• taking the blood thinning drug warfarin.

When Using This Product

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

• 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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

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 (1-800-222-1222) 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

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

Inactive Ingredients

citric acid, D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

Questions Or Comments?

1-844-912-4012

Package Label.Principal Display Panel

label - nighttime cold flu