CVS Children’s Nighttime Multi-Symptoms Cold 4 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:

If a skin reaction occurs, stop use and seek medical help right away.

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 5 doses in 24 hours, which is the maximum daily amount
• ▪with other drugs containing acetaminophen

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.
• ▪To make child sleepy
• ▪with any other drug containing diphenhydramine, even one used on the skin
• ▪in a child who is 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 the child have

• ▪liver disease
• ▪heart disease
• ▪high blood pressure
• ▪thyroid disease
• ▪diabetes
• ▪glaucoma
• ▪a breathing problem such as chronic bronchitis
• ▪persistent or chronic cough such as occurs with asthma
• ▪cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child is

• ▪taking the blood thinning drug warfarin
• ▪taking sedatives or tranquilizers

When using this product

• ▪do not use more than directed (see Overdose warning)
• ▪excitability may occur, especially in children
• ▪marked drowsiness may occur
• ▪sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• ▪nervousness, dizziness, or sleeplessness occur
• ▪pain, nasal congestion, or cough gets worse or lasts more than 5 days
• ▪fever gets worse or lasts more than 3 days
• ▪redness or swelling is present
• ▪new symptoms occur
• ▪cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

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

• ▪this product does not contain directions or complete warnings for adult use
• ▪do not give more than directed (see Overdose warning)
• ▪measure only with dosing cup provided
• ▪do not use dosing cup with other products
• ▪dose as follows or as directed by a doctor
• ▪children 6 years to 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in 24-hours period
• ▪children under 6 years of age: do not use

Other information

• ▪each 10 mL contains: sodium 4 mg
• ▪store at room temperature
• ▪do not refrigerate

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.