Rugby Acetaminophen

Dosage form: liquid
Ingredients: Acetaminophen 160mg in 5mL
Labeler: Rugby Laboratories, Inc.
NDC Code: 0536-0122

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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
WeightAgeDose
72 - 95 lbs11 years3 TSP
60 - 71 lbs9 - 10 years2 1/2 TSP
48 - 59 lbs6 - 8 years2 TSP
36 - 47 lbs4 - 5 years1 1/2 TSP
24 - 35 lbs2 - 3 years1 TSP
under 24 lbsunder 2 yearsask 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)

RUGBY   ACETAMINOPHEN
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-0122
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-0122-97118 mL in 1 BOTTLE
2NDC:0536-0122-85473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/28/2011
Labeler - Rugby Laboratories, Inc. (109178264)

Revised: 07/2011
 
Rugby Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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