DRKIDS CHILDRENS PAIN AND FEVER- acetaminophen 80mg/piece bar, chewable 
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 + Fever Soft Chews

Active ingredient (in each piece)

Acetaminophen 80 mg

Purpose

Pain reliever, fever reducer

Uses

the common cold

flu

headache

sore throat

toothache

Warnings

Liver warning: this product contains acetaminophen. Severe liver damage may occur if your child takes

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

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.

Keep Out of Reach Of Children

Keep out of reach of children.

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

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.

Ask a doctor before use if your child has liver disease

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 for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Weight (lb)Age (yr)Dose (piece)*
Under 24Under 2 yearsAsk a doctor
24-352-3 years2 pieces
36-474-5 years3 pieces
48-596-8 years4 pieces
60-719-10 years5 piceces
72-9511 years6 pieces

*or as directed by a doctor

Other Information

Inactive Ingredients

ammonium glycyrrhizate, flavors, geleol mono and diglycerides, glucode syrup, maltitol solution, maltodextrin, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

Questions or comments?

Call 1-941-202-3270

label PDPlabel continued

DRKIDS CHILDRENS PAIN AND FEVER 
acetaminophen 80mg/piece bar, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-2480
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
MALTITOL (UNII: D65DG142WK)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
NEOTAME (UNII: VJ597D52EX)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SUCROSE (UNII: C151H8M554)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CORN SYRUP (UNII: 9G5L16BK6N)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
POVIDONE K30 (UNII: U725QWY32X)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
Colorwhite (opaque, beige) Scorescore with uneven pieces
ShapeRECTANGLESize15mm
FlavorORANGE (Orange Vanilla Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73282-2480-124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/01/2023
Labeler - CalmCo LLC (079308308)
Registrant - CalmCo LLC (079308308)

Revised: 6/2023
Document Id: ff4b0528-39a1-80d5-e053-6394a90a8a83
Set id: ff4b0528-39a0-80d5-e053-6394a90a8a83
Version: 1
Effective Time: 20230629
 
CalmCo LLC