Maximum Strength Nighttime Cold and Flu 6 fl oz (180 mL)

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Uses

• •temporarily relieves these common cold and flu symptoms:•cough•nasal congestion•minor aches and pains•sore throat•headache•runny nose •sneezing
• •temporarily reduces fever
• •controls cough to help you get to sleep

Warnings

Liver Warning:

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

Allergy alert: Acetaminophen may cause severe skin reactions .Symptoms may include:

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

• •more than 6 doses in 24 hours, which is the maximum daily amount
• •with other drugs containing acetaminophen
• •3 or more alcoholic drinks daily while using this product

Do not use

for children under 12 years of age

• •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• •with any other drug containing diphenhydramine, even one used on the skin
• •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.

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)

• •liver disease
• •heart disease
• •high blood pressure
• •thyroid disease
• •diabetes
• •trouble urinating due to an enlarged prostate gland
• •glaucoma
• •a breathing problem such as emphysema or chronic bronchitis
• •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if

you are taking sedatives or tranquilizers

• •you are taking the blood thinning drug warfarin

When using this product

be careful when driving a motor vehicle or operating machinery

• •do not use more than directed
• •excitability may occur, especially in children
• •marked drowsiness may occur
• •alcohol, sedatives, and tranquilizers may increase drowsiness
• •avoid alcoholic drinks

Stop use and ask a doctor if

cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

• •nervousness, dizziness, or sleeplessness occur
• •pain, nasal congestion, 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

• •do not take more than directed (see Overdose warning)
• •do not take more than 6 doses in any 24-hour period
• •measure only with dosing cup provided
• •do not use dosing cup with other products
• •dose as follows or as directed by a doctor
• •mL= milliliter
• •adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
• •children under 12 years of age: do not use

Other information

• •each 20 mL contains: sodium 8 mg
• •low sodium
• •store at room temperature
• •do not refrigerate
• •dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, natural and artificial flavor, potassium citrate ,propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.