CHILDRENS PAIN AND FEVER- acetaminophen solution 
CalmCo 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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DrKids Children's Pain and Fever

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.

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.

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

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.

Ask a doctor or pharmacist before use if

your child is taking the blood thinning drug warfarin

Ask a doctor before use if your child has

liver disease

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 (YearsDose (mL)
under 24 lbsunder 2 yearsTalk to a doctor
24-35 lbs2-3 years1 Single-Use Vial (5mL)
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 dihyrate, xanthan gum.

Questions or Comments?

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

Package Art File- 4ct Carton

Package Art File- 4ct Carton package art file

CHILDRENS PAIN AND FEVER 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-0164(NDC:70302-126)
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
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MALTITOL (UNII: D65DG142WK)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73282-0164-14 in 1 CARTON02/01/2022
15 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/01/2022
Labeler - CalmCo LLC (079308308)
Registrant - CalmCo LLC (079308308)

Revised: 7/2023
Document Id: 0102eaa5-3cd0-0477-e063-6394a90a6037
Set id: 014029d4-764b-c5bd-e063-6294a90aa85f
Version: 4
Effective Time: 20230721
 
CalmCo LLC