Medically reviewed on August 7, 2017
Dosage form: liquid
Ingredients: Acetaminophen 160mg in 5mL
Labeler: Rugby Laboratories, Inc.
NDC Code: 0536-0122
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.
Acetaminophen 160 mg
Pain reliever-Fever reducer
temporarily reduces fever and relieves minor aches and pains caused by
- 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.
Allergy alert: 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 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 appear
- redness or swelling is present. These could be signs of a serious condition.
Keep out of reach of children.
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
- this product does not contain directions or complete warnings for adult use
- find right dose on chart. If possible, use weight to dose; otherwise, use age
- give dose every 4 hours while symptoms last
- do not give more than 5 doses in 24 hours
- use enclosed dosing cup only. Do not use with any other device.
- mL = milliliter
|72 - 95 lbs||11 years||15mL|
|60 - 71 lbs||9 - 10 years||12.5mL|
|48 - 59 lbs||6 - 8 years||10mL|
|36 - 47 lbs||4 - 5 years||7.5mL|
|24 - 35 lbs||2 - 3 years||5mL|
|under 24 lbs||under 2 years||ask a doctor|
- each 5 mL contains: sodium 1 mg
- store at 20 - 25°C (68 - 77°F)
artificial flavor, citric acid anhydrous, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol.
Distributed by: Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
|Labeler - Rugby Laboratories, Inc. (079246066)|
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.
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