Acetaminophen description, usages, side effects, indications, overdosage, supplying and lots more!

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Acetaminophen

Physicians Total Care, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each chewable tablet)

Acetaminophen 80 mg

Purposes

Pain Reliever/Fever Reducer

Acetaminophen Uses

Temporarily relieves minor aches and pain due to:

■ The common cold  ■ Flu  ■ Headache  ■ Sore throat

■ Toothache

Temporarily reduces fever.

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 other drug containing acetaminophen (prescription or non prescription). 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.


Ask a doctor before use if your child has

Ask a doctor or pharmacist before use if your child is

When using this product: Do not exceed recommended dose.

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 occur ■ Redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

This products does not contain directions or complete warnings for adult use.
■ Find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
■ Chew before swallowing
■ If needed, repeat dose every 4 hours while symptoms lasts
■ Do not give more than 5 times in 24 hours
■ Do not give for more than 5 days unless directed by a doctor.


Weight Age Tablets
Under 24 lbs
Under 2 years
Ask a doctor
24-35 lbs
2-3 years
2 tablets
36-47 lbs
4-5 years
3 tablets
48-59 lbs
6-8 years
4 tablets
60-71 lbs
9-10 years
5 tablets
72-95 lbs
11 years
6 tablets

Other Information

  • Phenylketonurics: Contain Phenylalanine 14 mg per tablet
  • Do not use if imprinted safety seal under cap is broken or missing
  • Store at room temperature in a dry place

Inactive Ingredients

Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.

Questions?



Principal Display Panel

Acetaminophen

NDC 54868-5625-0

*Compare to the active ingredient in Children's Chewable Tylenol®

Children's Chewable

AGES 2-6

Acetaminophen  Chewable Tablets

30 Tablets, 80 mg EACH

Fever reducer/ Pain reliever

ASPIRIN FREE ● IBUPROFEN FREE


See New Warnings Information

Acetaminophen

Acetaminophen TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54868-5625(NDC:0904-5256)
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
ASPARTAME
SILICON DIOXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
mannitol
povidone
STARCH, CORN
SODIUM CHLORIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
sorbitol
STEARIC ACID
Sucralose

Product Characteristics

Color Size Imprint Code Shape
pink 10 mm 1G ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, PLASTIC
2 NDC:54868-5625-0 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2006-06-29


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Be sure to consult your doctor before taking any medication!
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