DrugCite

ACETAMINOPHEN  - acetaminophen tablet 
Rugby Laboratories Inc.

Acetaminophen Tablets
For Children

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 Age Dose
72 - 95 lbs 11-12 years 4 – 6 tablets
60 - 71 lbs 9 - 10 years 4 – 5 tablets
48 - 59 lbs 6 - 8 years 4 tablets
36 - 47 lbs 4 - 5 years 3 tablets
24 - 35 lbs 2 - 3 years 2 tablets
under 24 lbs under 2 years ask 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 Type HUMAN OTC DRUG NDC Product Code (Source) 0536-3233
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 80 mg
Inactive Ingredients
Ingredient Name Strength
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
Color PINK (Light Pink) Score 2 pieces
Shape ROUND Size 10mm
Flavor FRUIT (fruit flavor) Imprint Code AP;051
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0536-3233-07 30 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 08/12/2022

Labeler - Rugby Laboratories Inc. (191427277)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
Name Address ID/FEI Operations
Advance Pharmaceutical Inc. 078301063 MANUFACTURE
Revised: 12/2012Rugby Laboratories Inc.