Childrens Acetaminophen Pain Relief & Fever Reducer 160 mg/5 mL

Childrens Pain Relief and Fever Reducer by

Drug Labeling and Warnings

Childrens Pain Relief and Fever Reducer by is a Otc medication manufactured, distributed, or labeled by Plastikon Healthcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHILDRENS PAIN RELIEF AND FEVER REDUCER- acetaminophen oral solution solution 
Plastikon Healthcare, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Childrens Acetaminophen Pain Relief & Fever Reducer 160 mg/5 mL

Children's Pain Relief and Fever Reducer
Acetaminophen Oral Solution 160 mg/ 5 mL Unit Dose Cup

Childrens Pain Relief and Fever Reducing 12 count pouch

Single Use Measurements

for easy, accurrate dosing.

Compare to the Active Ingredient in

Children's Tylenol® Pain + Fever Relief Liquid*

CORRECTDOSE®

Precise - Portable - Single-use

Children's

PAIN RELIEF

& FEVER REDUCING

For Ages: 2-3**

Acetaminophen Oral Solution

12

PRE-FILLED

SINGLE-USE

DOSES

CHERRY

Ibuprofen Free

Aspirin Free

2.04 FL. OZ (60 mL)

12 - 5 mL Individual Doses

Children's Pain Relief & Fever Reducer 160 mg / 5 mL Unit Dose Vial/Ampoule

Directions

  • do not exceed 5 doses (5 vials) in a 24 hour period
  • give the recommended number of vials below folloiwn gthe instructions under "How to Use" on the back panel
  • if the child is not in the listed weight range, consult a physician before use
  • empty each single-use vial required, of all liquid when dosing
  • this product does not include dosing or complete warnings for adult use

Age (yr)

Weight (lbs)

Dose (mL)

2-3 years

24-35 lbs

1 Single-use vial (5 mL) every 4 hours

Do not exceed 5 does in a 24 period

Children's Pain Relief & Fever Reducer 160 mg / 5 mL

Keep out of reach of children.

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

Children's Pain Relief & Fever Reducer 160 mg / 5 mL

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.

- if the child is allergic to acetaminophen or any other inactive ingredients in this product

____________________________________________________________________________

Ask a doctor before use if

  • the child has liver disease

____________________________________________________________________________

Ask a doctor or pharmacist before use

  • if the child is taking the blood thinning drug Warfarin

____________________________________________________________________________

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

These could be signs of a serious condition

Children's Pain Relief & Fever Reducer 160 mg / 5 mL

Inactive ingredientsAnhydrous Ctric acid, Cherry flavor, Glycerin, Propyl Paraben, Propylene Glycol, Purified Water, Sodium Benzoate, Sorbitol, Sucralose

Children's Pain Relief & Fever Reducer 160 mg / 5 mL

Uses temporarily relieves minor aches and pains due to:

  • muscular aches
  • backache
  • premenstrual and menstrual cramps
  • the common cold
  • headache
  • toothache
  • temporarily reduces fever

Children's Pain Relief & Fever Reducer 160 mg / 5 mL

Active ingredient (in each 5 mL unit) ­

Acetaminophen USP 160 mg

Children's Pain Relief & Fever Reducer 160 mg / 5 mL

Pain reliever / fever reducer

Children's Pain Relief & Fever Reducer 160 mg / 5 mL

Other information

- store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F)

- protect from excessive moisture

- do not use if foile lid seal is open or damaged

- see bottom of bag for lot number and expiration date

- sugar free, dye free, alcohol free

Children's Pain Relief & Fever Reducer 160 mg / 5 mL Unit Dosing Ampoule Pouch

children's Pain Relief & Fever Reducer Unit Pouch

CORRECTDOSE®

Precise - Portable - Single-use

Children's

PAIN RELIEF

&

Fever Reducer

Acetaminophen Oral Solution

Cherry

For Ages: 2-3**

1

PRE-FILLED

SINGLE-USE

DOSE

Lasts up to

4 HOURS

WARNING:

CHOKING HAZARD

-SMALL PARTS

KEEP OUT OF REACH

OF SMALL CHILDREN

0.17 FL. OZ (5 mL)

CHILDRENS PAIN RELIEF AND FEVER REDUCER 
acetaminophen oral solution solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62320-311
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 10.15 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62320-311-0512 in 1 POUCH02/01/202104/29/2022
11 in 1 POUCH
15 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/01/202104/29/2022
Labeler - Plastikon Healthcare, LLC (041717941)
Registrant - Plastikon Healthcare, LLC (041717941)
Establishment
NameAddressID/FEIBusiness Operations
Plastikon Healthcare, LLC041717941manufacture(62320-311)

Revised: 9/2022