FDA Label for Children Acetaminophen
View Indications, Usage & Precautions
Children Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Aarna Usa Inc.. 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.
Otc - Active Ingredient
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
Otc - Purpose
Purpose
Pain Reliever/Fever Reducer
Indications & Usage
Uses temporarily
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Warnings
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
- skin reddening
- blisters
- rash
- If a skin reaction occurs, stop use and seek medical help right away.
- 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.
- 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.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
Soar throat warning: if sore throat is severe, persists or more than 2 days, is accompanied or followed by fever headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
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.
When using this product: Do not exceed recommended dose (see overdose warning)
Stop use and ask a doctor if
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Other
Overdose warning. In case of overdose, get medical help or contact a Paoison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
- this product does not contain direction or complete warnings for adult use
- Shake well before using
- ml = milliliter
- find right dose on chart below
- if possible, use weight to dose; otherwise use age
- use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- if needed, repeat dose every 4 hourswhile symptoms last
- do not give more than 5 times in 24 hours
| Weight (lbs.) | Age (yrs.) | Dose (tsp or mL) |
| under 24 | under 2 | ask a doctor |
| 24 to 35 | 2 to 3 | 1 tsp or 5 mL |
| 36 to 47 | 4 to 5 | 1 1/2 tsp or 7.5 mL |
| 48 to 59 | 6 to 8 | 2 tsp or 10 mL |
| 60 to 71 | 9 to 10 | 2 1/2 tsp or 12.5 mL |
| 72 to 95 | 11 | 3 tsp or 15 mL |
Other Information store at room temperature 20o-25oC (68o-77oF). Protect from Freezing. Protect from light.
Inactive Ingredient
Inactive ingredients: Anhydrous Citric Acid, Bubble gum flavor, FD&C Red No 40, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.
Otc - Questions
Questions or comments? call toll-free 1-877-225-6999.
Manufactured for:
AARNA USA INC.
Leland, NC-28451
This product is not manufactured by or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Eixir.
Package Label.Principal Display Panel
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