Children's ACCUDIAL® Acetaminophen Oral Solution
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient Purpose (in each 5 mL = 1 teaspoon)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
Temporarily relieves minor aches and pains due to:
Temporarily reduces fever
- the common cold
- flu
- headache
- sore throat
- toothache
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 containing acetaminophen.
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
- If your child is allergic to acetaminophen or any of the inactive ingredients in this product.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if your child has liver disease.
Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
When using this product
Do not use more than directed.
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.
- New symptoms occur.
- Redness or swelling is present.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.
Directions
This product does not contain directions or complete warnings for adult use.
| under 6 mos. | ask a doctor |
| 6 mos. to under 2 | 2.5 mL or ½ tsp. |
| 2 to under 4 | 5 mL or 1 tsp. |
| 4 to under 6 | 7.5 mL or 1½ tsp. |
| 6 to under 9 | 10 mL or 2 tsp. |
| 9 to under 11 | 12.5 mL or 2½ tsp. |
| 11 to under 12 | 15 mL or 3 tsp. |
| or as directed by a doctor | |
| tsp. = teaspoon | mL = milliliter |
- shake well before using
- if needed, repeat dose every 4 hours
- do not use more than 5 times in 24 hours
- when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose.when weight is unknown: use the age chart on the rotating label.
- use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device
OTC - ASK DOCTOR SECTION
Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.
Other information
- each teaspoon contains: sodium 2 mg
- store between 20°-25°C (68°-77°F)
- tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.
Inactive ingredients
artificial flavor, citric acid anhydrous USP, D&C Red #33, FD&C Red #40, glycerin USP, non-crystalline sorbitol 70% USP, polyethylene glycol NF, propylene glycol, purified water, sodium benzoate, sodium saccharin.
Questions?
877-434-2036
DISTRIBUTED BY ACCUDIAL PHARMACEUTICAL, INC.Palm Beach Gardens, FL 33408