FDA Label for Childrens Acetaminophen
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 5 ML = 1 TEASPOON)
- PURPOSE
- USES
- LIVER WARNING
- SORE THROAT WARNING
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON
Childrens Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product R3 Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by: R3 Pharmaceuticals,LLC
Canton, MS 39046
Active Ingredient (In Each 5 Ml = 1 Teaspoon)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
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). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
Otc - When Using
When using this product do not exceed recommended dose (see overdose warning)
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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 even if you do not notice any signs or symptoms.
Directions
- do not give more than directed (see Liver and overdose warning)
- shake well before use
- this product does not contain directions or complete warnings for adult use
- use only with enclosed dosing cup
- repeat dose every 4 hours if needed
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor
- find right dose on chart below. If possible, use weight to dose, otherwise; use age.
Weight (lb) | Age (yr) | Dose (tsp or mL) |
---|---|---|
under 24 | under 2 years | ask a doctor |
24-35 | 2-3 years | 1 tsp or 5 mL |
36-47 | 4-5 years | 1 1/2 tsp or 7.5 mL |
48-59 | 6-8 years | 2 tsp or 10 mL |
60-71 | 9-10 years | 2 1/2 tsp or 12.5 mL |
72-95 | 11 years | 3 tsp or 15 mL |
Other Information
- each teaspoon contains: sodium 3 mg
- store at 20°-25°C (68°-77°F)
Inactive Ingredients
anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution
Questions?
Call 601-859-0038
Principal Display Panel - 118 Ml Bottle Carton
NDC 59999-001-04
SEE NEW WARNINGS INFORMATION
*Compare to the active ingredient in
Children's Tylenol® Oral Suspension*
Children's
Acetaminophen
oral suspension
80 mg per 1/2 teaspoon
(160 mg per 5 mL)
fever reducer/
pain reliever
AGE
2-11
YEARS
Grape Flavor
R3 Pharmaceuticals
4 FL OZ (118 mL)
* Please review the disclaimer below.