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Acetaminophen

Rugby Laboratories Inc.
Advance Pharmaceutical Inc.

Acetaminophen Tablets For Children




FULL PRESCRIBING INFORMATION

(in each tablet)

Acetaminophen 80 mg

Pain Reliever/Fever Reducer

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

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

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

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.

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

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

Call 1-800-645-2158

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

Duluth, Georgia 30097

  • Acetaminophen

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 label Item Code (Source) NDC:0536-3233
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
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 Size Imprint Code Shape
PINK (Light Pink) 10 mm AP;051 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-3233-07 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2002-08-12


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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