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RUGBY  ACETAMINOPHEN - acetaminophen liquid 
Rugby Laboratories, Inc.

Rugby
Pain
& Fever
ACETAMINOPHEN
ORAL SOLUTION

Drug Facts

Active ingredient

(in each TSP)

Acetaminophen 160 mg

Purpose

Pain reliever - Fever reducer

Uses

temporarily reduces fever and relieves minor aches and pains caused by:

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

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, 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 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

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 appear
  • redness or swelling is present

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. Quick 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
  • find right dose on chart
  • give dose every 4 hours while symptoms last
  • if possible, use weight to dose; otherwise, use age
  • do not give more than 5 doses in 24 hours
  • for accurate dosage, use measuring cup provided
Weight Age Dose
72 - 95 lbs 11 years 3 TSP
60 - 71 lbs 9 - 10 years 2 1/2 TSP
48 - 59 lbs 6 - 8 years 2 TSP
36 - 47 lbs 4 - 5 years 1 1/2 TSP
24 - 35 lbs 2 - 3 years 1 TSP
under 24 lbs under 2 years ask a doctor

Other information

  • store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

artificial cherry flavor, benzoic acid, citric acid, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose syrup

Questions or comments?

Call 1-800-645-2158,

9 AM - 5 PM ET, Monday - Friday

Children's Pain & Fever is distributed by Rugby Laboratories, Inc.
Duluth, Georgia 30097

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

ASPIRIN & ALCOHOL FREE

COMPARE TO
ACTIVE INGREDIENT IN
CHILDREN'S TYLENOL®*

NDC 0536-0122-97

Rugby®

RELIEVES
CHILDREN'S
Pain
&Fever
ACETAMINOPHEN
ORAL SOLUTION
CHERRY FLAVORED
Pain Reliever
Fever Reducer

• SATISFACTION GUARANTEED•
Rugby
OR YOUR MONEY BACK

4 fl oz (118 mL)

Principal Display Panel - 118 mL Bottle Carton

RUGBY   ACETAMINOPHEN
acetaminophen  liquid
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0536-0122
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (acetaminophen) Acetaminophen 160 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin  
Benzoic Acid  
Sorbitol  
Sodium Benzoate  
Anhydrous citric acid  
FD&C Red no. 40  
Water  
Sucrose  
Propylene glycol  
Cherry  
POLYETHYLENE GLYCOL 1450  
D&C RED NO. 33  
Product Characteristics
Color RED Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0536-0122-97 118 mL In 1 BOTTLE None
2 0536-0122-85 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 04/28/2011

Labeler - Rugby Laboratories, Inc. (109178264)
Revised: 07/2011Rugby Laboratories, Inc.