Childrens Accudial
Children's ACCUDIAL Pain reliever/ Fever reducer
FULL PRESCRIBING INFORMATION: CONTENTS*
- Active ingredient (in each 5 mL = 1 teaspoon)
- Purpose
- Childrens Accudial Uses
- Warnings
- Directions
- Childrens Accudial Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
FULL PRESCRIBING INFORMATION
Drug Facts
Active ingredient (in each 5 mL = 1 teaspoon)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Childrens Accudial Uses
Temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Temporarily reduces 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 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.
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.
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.
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:
- 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.
These could be signs of a serious condition.
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.
- 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
Age (yr) | Dose (mL or tsp) |
---|---|
tsp. = teaspoon | |
mL = milliliter | |
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 |
Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.
Childrens Accudial 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, corn syrup, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
Questions?
877-434-2036
DISTRIBUTED BY ACCUDIAL PHARMACEUTICAL, INC.
Palm Beach Gardens, FL 33408
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
Children's
ACCUDIAL®
Acetaminophen
Oral Suspension
Pain Reliever / Fever Reducer
For ages 6 mos. to
under 12 yrs. or 12-95 lbs.
Alcohol Free • Aspirin Free • Ibuprofen Free
Compares to the active
ingredient in Children's
Tylenol® Oral Suspension.
ROTATING
LABEL FOR
WEIGHT-BASED
DOSING
Grape
Flavor
4 FL.OZ. (120 mL)
80 mg per 1/2 teaspoon
(160 mg per 5 mL)
NDC 45014-136-04
Childrens AccudialAcetaminophen SUSPENSION
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