Acetaminophen by Rugby Laboratories Inc.
Dosage form: tablet
Ingredients: ACETAMINOPHEN 80mg
Labeler: Rugby Laboratories Inc.
NDC Code: 0536-3233
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.
(in each tablet)
Acetaminophen 80 mg
Pain Reliever/Fever Reducer
For the temporary relief of minor aches and pains due to:
- 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
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). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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
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 appear
- redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
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 correct dose below
- if possible use weight to dose, otherwise use age
- chew tablets before swallowing
- give dose every 4 hours while symptoms last
- do not give more than 5 doses in 24 hours
|72 - 95 lbs||11-12 years||4 – 6 tablets|
|60 - 71 lbs||9 - 10 years||4 – 5 tablets|
|48 - 59 lbs||6 - 8 years||4 tablets|
|36 - 47 lbs||4 - 5 years||3 tablets|
|24 - 35 lbs||2 - 3 years||2 tablets|
|under 24 lbs||under 2 years||ask a doctor|
- store at room temperature 15°-30°C (59°-86°F)
citric acid, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose syrup
Children's Pain & Fever is manufactured for Rugby Laboratories, Inc.
Duluth, Georgia 30097
|Labeler - Rugby Laboratories Inc. (191427277)|
|Registrant - Advance Pharmaceutical Inc. (078301063)|
|Advance Pharmaceutical Inc.||078301063||MANUFACTURE(0536-3233)|
Medically reviewed on Dec 10, 2018