Acetaminophen Oral Solution USP Alcohol Free
Active ingredient (in each 5 mL teaspoonful)
ACETAMINOPHEN 160 mg
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves minor aches and pains due to:
temporarily reduces fever
- •headache
- •muscular aches
- •backache
- •minor pain of arthritis
- •the common cold
- •toothache
- •premenstrual and menstrual cramps
Warnings
SPL UNCLASSIFIED SECTION
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
- ▪adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- ▪child takes more than 5 doses in 24 hours
- ▪taken with other drugs containing acetaminophen
- ▪adult has 3 or more alcoholic drinks every day while using this product
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
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.
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 of this product
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the user has liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the user is taking the blood thining drug warfarin.
Stop use and ask a doctor if
- •symptoms do not improve
- •new symptoms occur
- •pain or fever persists or gets worse
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.
SPL UNCLASSIFIED SECTION
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 children even if you do not notice any signs or symptoms.
Directions
| adults and children 12 years of age and over | 20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period |
| children 6 to under 12 years of age | 10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period |
| children 4 to under 6 years of age | 7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period |
| children 2 to under 4 years of age | 5 mL (160 mg) every 4 hours not to exceed 5 doses in a 24-hour period |
| children under 2 years of age | consult a doctor |
- ▪do not take more than directed (see overdose warning)
Other information
■ Each 5 mL contains: sodium 2 mg
■ store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
■ keep tightly closed ■ protect from light
■ a red, cherry flavored solution supplied in the following oral dosage forms:
650mg/20.3 mL unit dose cup
Overbagged with 5 x 20.3 mL unit dose cups per bag, NDC 55154-9449-5
Inactive ingredients:
Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.
MANUFACTURED BY:
Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com
Distributed by:Cardinal Health
Dublin, OH 43017
L53336121223
R10/20