FDA Label for Pain And Fever

Other

SAVE CARTON FOR COMPLETE DRUG FACTS

Drug Facts

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

Otc - Active Ingredient

Active ingredient (in each chewable tablet)

Acetaminophen 80 mg

Otc - Purpose

Purposes

Pain Reliever/Fever Reducer

Indications & Usage

Uses

• temporarily relieves minor aches and pains due to:
• the common cold
• flu
• headache
• sore throat
• toothache
• temporarily reduces fever.

Warnings

Warnings

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
• blisters
• rash

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.

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 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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

Directions

• 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

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

Storage And Handling

Other information

• Phenylketonurics: Contains Phenylalanine 14 mg per tablet
• Store at room temperature in a dry place

Inactive Ingredient

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

How Supplied

Product: 50090-3463

NDC: 50090-3463-0 30 TABLET, CHEWABLE in a BOTTLE, PLASTIC / 1 in a CARTON