Acetaminophen Oral Solution USP, 160 mg/5 mL

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Acetaminophen, USP 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

• headache
• muscular aches
• backache
• arthritis
• the common cold
• toothache
• menstrual cramps
• reduces fever

Warnings

Liver Warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

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

• skin reddening
• blisters
• rash

Ask a doctor before use

if you have health issues especially liver disease.

Ask a doctor or pharmacist before use

if you are taking other drugs, including the blood thinner warfarin.

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 more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
• if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Stop use and ask a doctor if

These could be signs of a serious condition.

• new symptoms occur such as rash, hives, itching or hoarseness
• redness or swelling is present
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• symptoms do not improve

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. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

Do not exceed recommended dosage.

Overdose Warnings: Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage.

• adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours
• children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.

Other information

If dispensed, dispense in a tight, light resistant container with a child-resistant cap.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)

Inactive ingredients

Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol.