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

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
• ▪very low sodium

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.