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

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Childrens Acetaminophen

Precision Dose Inc.

CHILDREN's ACETAMINOPHEN ORAL SUSPENSION


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

160 mg/5 mL
325 mg/10.15 mL
650 mg/20.3 mL

Grape Flavor

For Hospital Use Only

Drug Facts

Active Ingredient(in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/Fever reducer

Childrens Acetaminophen Uses

Temporarily relieves minor aches and pains due to:

  • the common cold
  • flu
  • headaches
  • sore throat
  • immunizations
  • toothaches
  • reduces fever

Warnings

Overdose warning

Taking more than the recommended dose can cause serious health problems, including 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.

Do not use with any other product containing acetaminophen.

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 5 days
  • fever gets worse or lasts for more than 3 days
  • sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting

Keep out of reach of children.

Directions

  • Use as directed per healthcare professional.
  • do not use more than directed (see overdose warning)
  • shake cups well before using
  • repeat dose every 4 hours, if needed
  • do not use more than 5 times in 24 hours

Other Information

  • each teaspoon contains: sodium 3 mg
  • store at room temperature 15° - 30°C (59° - 86°F)
  • This product is not the same concentration as Infant's Drops. Use as directed per healthcare professional.
  • see individual label or shipper label for lot number and expiration date

Inactive Ingredients

butylparaben, carboxymethylcellulose sodium, carrageenan, citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol

Alcohol Free, Aspirin Free, Ibuprofen Free

How Supplied

NDC 68094-593-58
5 mL per unit dose syringe
Fifty (50) unit dose syringes per shipper

NDC 68094-593-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-593-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-614-62
10.15 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-650-62
20.3 mL per unit dose cup
Thirty (30) cups per shipper

Mfg. By: Perrigo
515 Eastern Avenue
Allegan, MI 49010

Pkg. By: Precision Dose, Inc.
722 Progressive Lane
S. Beloit, IL 61080

LI806
Rev. 02/10

PRINCIPAL DISPLAY PANEL - 160 mg/5 mL Cup Lid

NDC 68094-593-59

PrecisionDose™

Children's ACETAMINOPHEN
Oral Suspension
160 mg/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

Childrens Acetaminophen

PRINCIPAL DISPLAY PANEL - 325 mg/10.15 mL Cup Lid

NDC 68094-614-59

PrecisionDose™

Children's ACETAMINOPHEN
Oral Suspension
325 mg/10.15 mL

Delivers 10.15 mL Shake Well
Each 5 mL contains Sodium 3 mg
Alcohol Free Aspirin Free Ibuprofen Free

Store at Room Temp (59°-86°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080

Childrens Acetaminophen

PRINCIPAL DISPLAY PANEL - 650 mg/20.3 mL Cup Lid

NDC 68094-650-59

PrecisionDose™

Children's ACETAMINOPHEN
Oral Suspension
650 mg/20.3 mL

Delivers 20.3 mL Shake Well
Each 5 mL contains Sodium 3 mg
Alcohol Free Aspirin Free Ibuprofen Free

Store at Room Temp (59°-86°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080

Childrens Acetaminophen

Childrens Acetaminophen

Acetaminophen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68094-614(NDC:0113-0130)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
CARRAGEENAN
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
FD&C BLUE NO. 1
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
cellulose, microcrystalline
propylene glycol
water
SODIUM BENZOATE
sorbitol

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68094-614-59 10.15 in 1 CUP, UNIT-DOSE
2 10 in 1 TRAY
3 NDC:68094-614-62 3 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2008-03-21


Childrens Acetaminophen

Acetaminophen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68094-593(NDC:0113-0130)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
CARRAGEENAN
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
FD&C BLUE NO. 1
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
cellulose, microcrystalline
propylene glycol
water
SODIUM BENZOATE
sorbitol

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68094-593-59 5 in 1 CUP, UNIT-DOSE
2 NDC:68094-593-59 5 in 1 CUP, UNIT-DOSE
3 5 in 1 SYRINGE, PLASTIC
4 10 in 1 BAG
5 NDC:68094-593-58 5 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-10-25


Childrens Acetaminophen

Acetaminophen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68094-650(NDC:0113-0130)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
CARRAGEENAN
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
FD&C BLUE NO. 1
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
cellulose, microcrystalline
propylene glycol
water
SODIUM BENZOATE
sorbitol

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68094-650-59 20.3 in 1 CUP, UNIT-DOSE
2 10 in 1 TRAY
3 NDC:68094-650-62 3 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2008-03-21


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