Rugby Pain & Fever APAP Chewable Tablets
SPL UNCLASSIFIED SECTION
SAVE CARTON FOR COMPLETE DRUG FACTS
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each chewable tablet)
Acetaminophen 80 mg
OTC - PURPOSE SECTION
Purposes
Pain Reliever/Fever Reducer
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
- temporarily reduces fever.
WARNINGS SECTION
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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.
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
OTC - DO NOT USE SECTION
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 SECTION
Ask a doctor before use if your child has liver disease.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
When using this product,do not exceed recommended dose (see overdose warning).
OTC - STOP USE SECTION
Stop use and ask a doctor if
These could be signs of a serious condition.
- 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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
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 SECTION
Directions
| Weight | Age | Dosage |
| 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 |
- 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
STORAGE AND HANDLING SECTION
Other information
- Phenylketonurics: Contains Phenylalanine 14 mg per tablet
- Store at room temperature in a dry place
INACTIVE INGREDIENT SECTION
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 SECTION
Questions or comments?
Call 1-800-645-2158
SPL UNCLASSIFIED SECTION
Distributed by: Rugby Laboratories
17177 N. Laurel Park Drive, Suite 233
Livonia, MI 48152
www.rugbylaboratories.com
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
HOW SUPPLIED
Product: 50090-3463
NDC: 50090-3463-0 30 TABLET, CHEWABLE in a BOTTLE, PLASTIC / 1 in a CARTON