FDA Label for Nitetime Cold And Flu

Active Ingredients (In Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purposes

Pain reliever/fever reducer

Cough suppressant 

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
• runny nose & sneezing

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4 doses in 24 hrs, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

Sore throat warning

If sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

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.

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 sleep

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 occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to 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
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives & 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.

Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

• take only as directed - see Overdose warning
• do not exceed 4 doses per 24 hrs                                                                   

adults & children 12 yrs & over	2 softgels with water every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

• when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Other Information

• store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Nitetime Cold & Flu 10 SOFTGELS

NDC 51013-184-01

^*Compare to the active ingredients in VICKS^® NyQuil^® Cold & Flu