Childrens Pain Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Pain Relief

GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

Healthcare 44-447




FULL PRESCRIBING INFORMATION

  (in each tablet)

Acetaminophen 80 mg

Pain reliever / fever reducer

  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • flu
  • sorethroat
  • toothache
  • temporarily reduces fever

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.

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product
  • liver disease
  • taking the blood thinning drug warfarin
  • do not exceed recommended dosage
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center 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 warning for adult use
  • find the right dose on chart. If possible, use weight to dose; otherwise, use age.
  • dissolve in mouth or chew before swallowing
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
 Weight (lb)  Age (yr)  Tablets
 under 24  under 2  Ask a doctor
 24-35  2-3  2
 36-47  4-5  3
 48-59  6-8  4
 60-71  9-10  5
 72-95  11  6
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

citric acid, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrose, ethylcellulose, flavors, magnesium stearate, mannitol, polyethylene, povidone, stearic acid, sucralose

1-800-426-9391

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

HEALTHCARE™

NDC 64092-031-20

Fever Reducer • Ibuprofen Free

Children's

ACETAMINOPHEN

SEE NEW WARNINGS INFORMATION

AGES 2-6

Compare to the active

ingredient in Children's

Tylenol® Meltaways*

Rapid Tabs

20 Tablets 80 mg EACH

Bubble Gum Flavor

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844     REV0410C44709

Distributed by:

Great Lakes Wholesale & Mareting L.L.C.

3729 Patterson Ave., S.E.

Grand Rapids, MI 49512

www.glwholesale.com

Childrens Pain Relief
Product Packaging

Childrens Pain Relief

Acetaminophen TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64092-031
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. 27
D&C RED NO. 30
DEXTROSE
ETHYLCELLULOSES
MAGNESIUM STEARATE
mannitol
povidone
STEARIC ACID
Sucralose

Product Characteristics

Color Size Imprint Code Shape
PINK 13 mm 44;447 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, PLASTIC
2 NDC:64092-031-20 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-02-03


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