Childrens Pain and Fever by PAI Holdings, LLC Childrens Pain and Fever

Childrens Pain and Fever by

Drug Labeling and Warnings

Childrens Pain and Fever by is a Otc medication manufactured, distributed, or labeled by PAI Holdings, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHILDRENS PAIN AND FEVER- childrens pain and fever suspension 
PAI Holdings, LLC dba PAI Pharma

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Childrens Pain and Fever

Active ingredient

(in each 5 mL)
Acetaminophen 160 mg

Purpose

Pain reliever/ fever reducer

Uses temporarily:

reduces fever
 relieves minor aches and pain due to:
  the common cold      flu                headache
  sore throat                toothache

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

Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
 skin reddening  blisters  rash

If a skin reaction occurs, stop use and seek medical help right
away.

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 drug containing acetaminophen (prescription
    or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if your child has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if your child has

 liver disease

Ask a doctor or pharmacist before use if your child is taking
the blood thinning drug warfarin

When using this product do not exceed the recommended dose (see overdose warning).

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: In 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 sign or symptoms.

Directions

this product does not contain directions or complete
  warnings for adult use
do not take more than directed (see overdose warning)
shake well before using

mL = milliliter
 find right dose on chart below. If possible, use weight to
    dose; otherwise, use age.
remove the child protective cap and squeeze your child’s
    dose into the dosing cup
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

 Weight (lb) Age (yr) Dose (mL)*
 under 24 under 2 years ask a doctor
 24-35 2-3 years 5 mL
 36-47 4-5 years 7.5 mL
 48-59 6-8 years 10 mL
 60-71 9-10 years 12.5 mL
 72-95 11 years 15 mL

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed
for use with this product. Do not use any other dosing device.

Other information

each 5 mL contains: sodium: 2 mg
store at 20° to 25°C (68° to 77°F)
do not use if printed neckband is broken or missing

Inactive ingredients

acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium
benzoate, sorbitol solution, veegum and xanthan gum.

Questions or Comments?

1-800-845-8210

**This product is not manufactured or distributed by
Johnson & Johnson Consumer Inc., distributor of
Children’s Tylenol® Oral Suspension.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2022 CVS/pharmacy
CVS.com® 1-800-SHOP CVS

Principal Display Panel

Compare to the active ingredient in Children’s Tylenol® Oral Suspension**

Suspension Liquid

NDC: 0121-0975-08

Children’s Pain & Fever

ACETAMINOPHEN

160 mg / 5 mL

Pain reliever; Fever reducer

Ages 2 to 11 years

Free of:

  Added Alcohol

  Aspirin

Ibuprofen 

Cherry Flavor

Use ONLY Enclosed Dosing Cup

Actual Bottle Size on Side Panel

8 FL OZ (237 mL)

8oz-cherry flavor

Childrens Pain and Fever


CHILDRENS PAIN AND FEVER 
childrens pain and fever suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0121-0975
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0121-0975-081 in 1 CARTON11/21/202205/31/2024
1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01311/21/202205/31/2024
Labeler - PAI Holdings, LLC dba PAI Pharma (044940096)

Revised: 1/2024