The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
SAVE CARTON FOR COMPLETE DRUG FACTSDrug Facts
Rugby Laboratories17177 N. Laurel Park Drive, Suite 233Livonia, MI 48152www.rugbylaboratories.comDO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Otc - Active Ingredient
Active ingredient (in each chewable tablet)Acetaminophen 80 mg
Otc - Purpose
PurposesPain Reliever/Fever Reducer
Indications & Usage
- Usestemporarily relieves minor aches and pains due to:the common coldfluheadachesore throattoothachetemporarily reduces fever.
- WarningsLiver 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 amountwith other drugs containing acetaminophenAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddeningblistersrashIf 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.
Otc - Do Not Use
- 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
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
Otc - When Using
When using this product,do not exceed recommended dose (see overdose warning).
Otc - Stop Use
- Stop use and ask a doctor ifpain gets worse or lasts more than 5 daysfever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
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.
Dosage & Administration
- Directionsthis 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 swallowingif needed, repeat dose every 4 hours while symptoms lastdo not give more than 5 times in 24 hoursdo not give more than 5 days unless directed by a doctorWeightAgeDosageUnder 24 lbsUnder 2 yearsAsk a doctor24-35 lbs2-3 years2 tablets36-47 lbs4-5 years3 tablets48-59 lbs6-8 years4 tablets60-71 lbs9-10 years5 tablets72-95 lbs11 years6 tablets
Storage And Handling
- Other informationPhenylketonurics: Contains Phenylalanine 14 mg per tabletStore 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.
Otc - Questions
Questions or comments? Call 1-800-645-2158
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