Acetaminophen
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 5 mL teaspoonful)
Acetaminophen, USP 160 mg
Purpose
Pain reliever/fever reducer
Uses
For the temporary relief of minor aches and pains associated with:
- the common cold
- flu
- sore throat
- headache
- toothache
- and to reduce fever
Warnings
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs that contain acetaminophen
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
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.
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if your child has liver disease.
Ask a doctor or pharmacist before use
if your child is taking the blood thinning drug warfarin.
Stop use and ask a doctor if
These could be signs of a serious condition.
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear.
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 for adults as well as for children even if you do not notice any signs or symptoms.
Directions
| Under 24 | Under 2 | Consult a doctor |
| 24 to 35 | 2 to under 4 | 5 mL (1 tsp) |
| 36 to 47 | 4 to under 6 | 7.5 mL (1 1/2 tsp) |
| 48 to 59 | 6 to under 9 | 10 mL (2 tsp) |
| 60 to 71 | 9 to under 11 | 12.5 mL (2 1/2 tsp) |
| 72 to 95 | 11 to under 12 | 15 mL (3 tsp) |
- this product does not contain directions or complete warnings for adult use
- use only the enclosed dosing cup designed for use with this product
- if possible, use weight to dose, otherwise use age
- dose may be repeated every 4 hours, while symptoms persist, up to five times a day or as directed by a doctor
Other information
- Each 5 mL contains: Sodium 3 mg
- 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, Sodium Saccharin, Sorbitol Solution, Sucralose.
Questions?
You may report side effects by calling Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-221-7294 or FDA at 1-800-FDA-1088.
HOW SUPPLIED
Product: 50090-6059
NDC: 50090-6059-0 118 mL in a BOTTLE, PLASTIC