Pain and Fever by RUGBY LABORATORIES
Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 80mg
Labeler: RUGBY LABORATORIES
NDC Code: 0536-1014
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.
SAVE CARTON FOR COMPLETE DRUG FACTS
Active ingredient (in each chewable tablet)
Acetaminophen 80 mg
Pain Reliever/Fever Reducer
- temporarily relieves minor aches and pains due to:
- the common cold
- sore throat
- temporarily reduces fever.
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
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.
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 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
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).
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 occur
- redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
- this product does not contain directions or warnings for adult use.
- find right dose on chart below. If possible, use weight to dose; otherwise use age.
- chew before swallowing
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
|Under 24 lbs||Under 2 years||Ask a doctor|
|24-35 lbs||2-3 years||2 tablets|
|36-47 lbs||4-5 years||3 tablets|
|48-59 lbs||6-8 years||4 tablets|
|60-71 lbs||9-10 years||5 tablets|
|72-95 lbs||11 years||6 tablets|
- Phenylketonurics: Contains Phenylalanine 14 mg per tablet
- Store at room temperature in a dry place
Inactive ingredients Aspartame, Colloidal Silicon Dioxide, D&C Red #27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural and Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.
Questions or comments?
Distributed by: Rugby Laboratories
17177 N. Laurel Park Drive, Suite 233
Livonia, MI 48152
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
|PAIN AND FEVER
acetaminophen tablet, chewable
|Labeler - RUGBY LABORATORIES (079246066)|
|Registrant - Gemini Pharmaceuticals, Inc. (055942270)|
|Gemini Pharmaceuticals, Inc.||055942270||manufacture(0536-1014)|