Childrens Pain and Fever Cherry

Children Pain and Fever by

Drug Labeling and Warnings

Children Pain and Fever by is a Otc medication manufactured, distributed, or labeled by Method Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHILDREN PAIN AND FEVER- acetaminophen liquid 
Method Pharmaceuticals, 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.

----------

Childrens Pain and Fever Cherry

Children’s Pain & Fever

Acetaminophen Liquid 160 mg/5 mL
Pain Reliever / Fever Reducer
Oral Solution
Alcohol Free/ Aspirin Free/ Ibuprofen Free
Ages 2-11 Years
Cherry Flavor

Drug Facts

Active ingredient (in each 5 mL teaspoonful

Acetaminophen, USP 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • 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 other drugs 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 recommended dose (see overdose warning)

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or last for 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 signs or symptoms.

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see overdose warning)
  • mL = milliliter
  • find the right dose on chart below. If possible, use weight to dose: otherwise, use age.
  • remove the child protective cap and dispense 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 24Under 2 years ask a doctor
24-352-3 years5 mL
36-474-5 years7.5 mL
48-596-8 years10 mL
60-719-10 years12.5 mL
72-9511 years15 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 3 mg
  • store at 20°C to 25°C (68°F to 77°F)
  • do not use if seal is broken or missing

Inactive Ingredients

FD&C Red #40, Flavor, Glycerin, Masking Agent, Polyethylene Glycol, Citric Acid, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol

Questions or comments?

1-877-250-3427

Manufactured for:
Method Pharmaceuticals, LLC
Fort Worth, Texas 76118

Rev. 04/2020

Principal Display Panel

NDC: 58657-521-04
Method Pharmaceuticals
Children’s
Pain & Fever
Acetaminophen 160 mg per 5 mL
Cherry Flavor
4 fl. Oz. (118 mL)

NDC: <a href=/NDC/58657-521-04>58657-521-04</a>
Method Pharmaceuticals
Children’s
Pain & Fever
Acetaminophen 160 mg per 5 mL
Cherry Flavor
4 fl. Oz. (118 mL)

CHILDREN PAIN AND FEVER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58657-521
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58657-521-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/01/202012/31/2021
Labeler - Method Pharmaceuticals, LLC (060216698)

Revised: 12/2021