FDA Label for Acetaminophen
View Indications, Usage & Precautions
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association 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.
Active Ingredient Purpose(In Each 5 Ml)
Acetaminophen 160 mg ............... Pain reliever/fever reducer
Uses Temporarily:
- reduces fever
- relieves minor aches and pains
- the common cold
- headache
- flu
- sore throat
- toothache
due to:
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
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
When using this product do not exceed recommended dose (see overdose warning)
Do Not Use
- with any other drug containing acetaminophen (prescription or non-prescription). 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
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
Stop Use And Ask A Doctor If
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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 for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see overdose warning)
- shake well before using
- ml= milliliter
- find right dose on chart below.
- only use enclosed measuring syringe
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
Weight (Ib)
Age (yr)
Dose (mL)
or as directed by doctor
Under 24
Under 2 years
Ask a doctor
24-35
2-3 years
5 mL
If possible, use weight to dose; otherwise, use age.
Other Information
- store between 20° -25°c (68°-77 °F)
- protect from freezing
- protect from light
Questions or comments?
1-800-935-2362 (Mon-Fri 9am-5pm EST)
Inactive Ingredients
acesulfame potassium, avicel, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N & AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum
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