CVS Nighttime Sleep-aid Pain Reliever

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 1000 mg

Diphenhydramine HCl 50 mg

Purpose

Pain reliever

Nighttime sleep-aid

Uses

• ▪for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

Allergy Alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:

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

• ▪adult takes more than 4 doses (30 mL each) in 24 hrs., which is the maximum daily amount for this product
• ▪taken with other drugs containing acetaminophen
• ▪3 or more alcoholic drinks every day while using this product

OTC - DO NOT USE SECTION

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.
• ▪for children under 12 years of age
• ▪with any other product containing diphenhydramine, even one used on skin.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

• •liver disease
• •a breathing problem such as emphysema or chronic bronchitis
• •glaucoma
• •difficulty in urination due to enlargement of the prostate gland
• •very low sodium

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

When using this product

• •avoid alcoholic beverages
• •drowsiness will occur
• •do not drive a motor vehicle or operate machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if

These could be signs of a serious condition.

• •pain gets worse or lasts more than 10 days
• •fever gets worse or lasts more than 3 days
• •new symptoms occur
• •Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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. In case of overdose, get medical help or contact a Poison Control Center right away at 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

take only one dose (30 mL) per day (24 hours)

Only use dose cup provided

Other information

• ▪each 30 mL contains: sodium 10 mg
• ▪store at room temperature

Inactive ingredients

citric acid, flavors, FD&C Blue No. 1, FD&C Red No. 40, glycerin, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose.