Childrens Acetaminophen by Pharmaceutical Associates, Inc.
Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Pharmaceutical Associates, Inc.
NDC Code: 0121-1781
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Alcohol Free / Aspirin Free
(in each 5 mL teaspoonful)
Acetaminophen 160 mg
Pain reliever/fever reducer
- reduces fever
- relieves minor aches and pain due to:
- the common cold
- sore throat
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
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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.
- 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 or pharmacist before use if your child is taking the blood thinning drug warfarin
When using this product, do not exceed the recommended dose (see overdose warning)
- 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 the reach of children.
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 children even if you do not notice any sign or symptoms.
- this product does not contain directions or complete warnings for adult use
- do not take more than directed (see overdose warning)
- shake well before using
- mL = milliliter; tsp = teaspoonful
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
|Weight (lbs)||Age (yr)||Dose (mL or tsp)|
|Under 24||Under 2||Ask a doctor|
|24-35||2-3 years||5 mL (1 tsp)|
|36-47||4-5 years||7.5 mL (1 ½ tsp)|
|48-59||6-8 years||10 mL (2 tsp)|
|60-71||9-10 years||12.5 mL (2 ½ tsp)|
|72-95||11 years||15 mL (3 tsp)|
- sodium content: 2 mg/5 mL
- store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]
- protect from freezing
- a red, berry flavored suspension supplied in the following oral dosage form:
NDC 0121-1781-05: 5 mL unit dose cup
NDC 0121-1781-00: Case contains 100 unit dose cups of 5 mL (0121-1781-05) packaged in 10 trays of 10 unit dose cups each.
Acesulfame K, butylparaben, citric acid, corn syrup, FD&C Red No. 40, flavoring, glycerin, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.
You may also report serious side effects to this phone number.
Associates, Inc. Greenville, SC 29605
|Labeler - Pharmaceutical Associates, Inc. (044940096)|
|Pharmaceutical Associates, Inc.||097630693||manufacture(0121-1781)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.