[Rugby Laboratories Inc.]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
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
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.
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|
citric acid, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose syrup
Questions or Comments
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)|