CHILDRENS PAIN AND FEVER- acetaminophen 160mg/5ml solution 
Calmco LLC

----------

DrKids Children's Pain and Fever

DRUG FACTS

Active Ingredient (in each 5mL)

Acetaminophen, 160mg

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 your child takes • more than 5 doses in 24 hours, which is the maximum daily amount for this product • 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 is allergic to acetaminophen or any of the inactive ingredients in this product

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

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

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt 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)

• use the chart below to confirm dose. If possible, use weight to confirm, otherwise use age

• give the recommended number of vials below following the instructions under "Easy to Use" on the side panel.

• empty each Single-Use Vial required of all liquid when dosing

• if needed, repeat dose every 4 hours while symptoms last

• do not give more than 5 times in 24 hours

• do not give for more than 5 days unless directed by a doctor

Dosing Chart

Weight (lbs)Age (Years)Dose (mL)
under 24 lbsunder 2 yearsTalk to a doctor
24 -35 lbs2 - 3 years1 Single-Use Vial (5 mL)
36 - 47 lbs4-5 yearsTalk to a doctor
48 - 71 lbs6-10 years2 Single-Use Vial (10 mL)
72 - 95 lbs11 years3 Single-Use Vial (15 mL)

Other information

Inactive ingredients

citric acid, cherry flavor, edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Questions or Comments?

+1 941-202-3270 or visit www.DrKids.com

Package

Package

Package

Package - 4ct

Package 4ct

CHILDRENS PAIN AND FEVER 
acetaminophen 160mg/5ml solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-0011
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
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MALTITOL (UNII: D65DG142WK)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73282-0011-120 in 1 CARTON08/06/2021
15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01308/06/202105/10/2025
CHILDRENS PAIN AND FEVER 
acetaminophen 160mg/5ml solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-0115
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
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MALTITOL (UNII: D65DG142WK)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73282-0115-44 in 1 CARTON01/11/2022
15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01308/06/202105/26/2024
Labeler - Calmco LLC (079308308)

Revised: 5/2024
Document Id: 1934b424-9a44-12a7-e063-6394a90adb3a
Set id: c8eb1154-3f44-6aea-e053-2995a90af351
Version: 6
Effective Time: 20240524
 
Calmco LLC