Your browser does not support JavaScript! ACETAMINOPHEN TABLET [RUGBY LABORATORIES INC.]
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ACETAMINOPHEN tablet
[Rugby Laboratories Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredient

(in each tablet)

Acetaminophen 80 mg

Purpose

Pain Reliever/Fever Reducer

Uses

For the temporary relief of minor aches and pains due to:

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

WARNINGS

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 correct dose below
  • if possible use weight to dose, otherwise use age
  • chew tablets before swallowing
  • give dose every 4 hours while symptoms last
  • do not give more than 5 doses in 24 hours
Weight AgeDose
72 - 95 lbs11-12 years4 – 6 tablets
60 - 71 lbs9 - 10 years4 – 5 tablets
48 - 59 lbs6 - 8 years4 tablets
36 - 47 lbs4 - 5 years3 tablets
24 - 35 lbs2 - 3 years2 tablets
under 24 lbsunder 2 yearsask a doctor

Other Information

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

Inactive Ingredients

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

Children's Pain & Fever is manufactured for Rugby Laboratories, Inc.

Duluth, Georgia 30097

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C:\Users\advance\Pictures\rugby_apap.jpg

18 mL Bottle Carton

ASPIRIN FREE

NDC 0536-3233-07

Rugby

RELIEVES
CHILDREN’S
Pain
& Fever
ACETAMINOPHEN
Chewable Tablets
FRUIT FLAVORED
Pain Reliever
Fever Reducer

30 Tablets

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-3233
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C RED NO. 33 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOL 1450 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
Product Characteristics
ColorPINK (Light Pink) Score2 pieces
ShapeROUNDSize10mm
FlavorFRUIT (fruit flavor) Imprint Code AP;051
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3233-0730 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34308/12/2002
Labeler - Rugby Laboratories Inc. (191427277)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063MANUFACTURE(0536-3233)

Revised: 12/2012
 
Rugby Laboratories Inc.

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