DR KIDS PAIN AND FEVER- acetaminophen solution

Dr Kids by

Drug Labeling and Warnings

Dr Kids by is a Otc medication manufactured, distributed, or labeled by CalmCo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient and Purpose

• Active ingredient (in each 5 mL vial): Purpose
• Acetaminophen 160 mg...............: Pain reliever/fever reducer

PURPOSE

• Active ingredient (in each 5mL vial): Purpose
• Acetaminophen 160 mg.....................: Pain reliever/ fever reducer

Uses

For the temporary relief of minor aches and pains due to

• sore throat
• headache
• and to reduce fever

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 acetaminophen

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

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

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
• edness or swelling is present
• any new symptoms appear

Keep out of reach of children.

In case of accidental 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 exceed 5 doses in a 24-hour period (see liver warning)
• follow the “Easy to Use” instructions on the pouch

corresponds to your child’s age use the dose that

• Age (Years): Dose*
• under 2: consult a doctor
• 2 to under 6: 1 vial (5 mL)
• 6 to 11: 2 vials (10 mL)

*dose may be repeated every 4 hours while symptoms persist, up to five times a day or as directed by a doctor.

Other information

• each 5 mL vial contains: sodium 2 mg
• store between 68-77°F (20-25°C)
• do not use if pouch or vial is punctured, torn or open

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose, FD&C red #40, flavors, glycerin, propylene glycol, sodium benzoate, sorbitol, sucralose, xylitol, water

Questions or comments?

+1 941-202-3270 (M-F) 9AM-5PM EST or visit www.DrKids.com

Distributed by: CalmCo LLC, Sarasota, FL 34240

Principal Display Panel

INGREDIENTS AND APPEARANCE

DR KIDS  PAIN AND FEVER
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73282-2522
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XYLITOL (UNII: VCQ006KQ1E)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73282-2522-1	30 in 1 POUCH	03/12/2025
1		5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/12/2025

Labeler - CalmCo LLC (079308308)