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

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Childrens Chewable Acetaminophen

Gemini Pharmaceuticals, Inc. dba Plus Pharma

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients (in each chewable tablet)

Acetaminophen 80 mg

Purpose

Pain Reliever/Fever Reducer

Childrens Chewable 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 a pharmacist.
■ If your child is allergic to acetaminophen or any of the inactive ingredients in this products.


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 warning 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
  • Store at room temperature in a dry place

Inactive Ingredients



Questions?

If you have any questions or comments, or to report an adverse drug event, please contact (800) 795-9775.

Principal Display Panel

See New Warning Information

PlusPHARMATM

Children's Chewable

ACETAMINOPHEN

PAIN RELIEVER/FEVER REDUCER

                CONTAINS NO ASPIRIN

*Compare the active ingredients to  Children Chewable Tylenol®

30 Chewable Tablet    ■ 80 mg EachChildrens Chewable Acetaminophen

Rev. 06/10

Do not use if imprinted seal under cap is broken or missing.

Childrens Chewable Acetaminophen

Acetaminophen TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51645-711
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 NDC:51645-711-30 30 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2010-12-03


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