Childrens Pain and Fever Acetaminophen

Rugby

Children's Pain & Fever Acetaminophen Oral Suspension

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 5 mL)
• Purpose
• Childrens Pain and Fever Acetaminophen Uses
• Warnings
  • Liver warning
  • Sore throat warning
  • Stop use and ask a doctor if
• Directions
• Childrens Pain and Fever Acetaminophen Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain Reliever / Fever Reducer

Childrens Pain and Fever Acetaminophen Uses

temporarily reduces fever and relieves minor aches and pains caused by

• headache
• common cold
• flu
• toothache
• sore throat

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

Sore throat warning

If sore throat is severe, lasts for more than 2 days or 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

When using this product, do not exceed recommended dose

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
• redness or swelling is present
• any new symptoms appear

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. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use
• shake well before using
• if possible, use weight to dose; otherwise use age
• use only with enclosed syringe. Do not use with any other dosing device
• push air out of syringe. Firmly push syringe into bottle opening.
• turn bottle upside-down and pull syringe to the correct dose
• dispense liquid slowly into child's mouth, towards inner cheek
• give dose every 4 hours while symptoms last
• do not give more than 5 doses in 24 hours

24-35 lbs (2-3 years): 5 mL

Under 24 lbs (under 2 years): ask a doctor

Childrens Pain and Fever Acetaminophen Other information

store at at 20°-25° C (68°-77° F)

Inactive ingredients

Artificial flavor, citric acid anhydrous, corn syrup, FD&C Red #40, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

Call 1-800-645-2158
9 am-5 pm ET, Monday-Friday

Pain & Fever Acetaminophen Oral Suspension is distributed by Rugby Laboratories, Inc.

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

NDC 0536-3606-96
ASPIRIN & ALCOHOL FREE

COMPARE TO
ACTIVE INGREDIENT IN
INFANTS' TYLENOL ^® *

Rugby ^®

RELIEVES CHILDREN'S
Pain
& Fever

Acetaminophen Oral Suspension
160 mg/5 mL
Pain Reliever - Fever Reducer
CHERRY FLAVORED
2 fl oz (60 mL)

See New
Dosing Directions

For use with
enclosed
syringe

• SATISFACTION GUARANTEED •
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