Dr Kids Pain+ Fever

Dr Kids Pain+ Fever
SPL v1
SPL
SPL Set ID 2ee6df99-727a-34c6-e063-6294a90a6bbc
Route
ORAL
Published
Effective Date 2025-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Sucralose Sorbitol Sodium Benzoate Glycerin Water Propylene Glycol Xylitol Carboxymethylcellulose Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-12

Description

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


Medication Information

Description

Active ingredient (in each 5 mL 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
Section 55105-1
Active ingredient (in each 5 mL vial) Purpose
Acetaminophen 160 mg............... Pain reliever/fever reducer

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

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.

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

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

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.

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


Structured Label Content

Uses

For the temporary relief of minor aches and pains due to

  • sore throat
  • headache
  • and to reduce fever
Section 55105-1 (55105-1)
Active ingredient (in each 5 mL vial) Purpose
Acetaminophen 160 mg............... Pain reliever/fever reducer

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

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.

Do Not Use (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

Other Information (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 (Inactive ingredients)

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

Questions Or Comments? (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

Stop Use and Ask A Doctor If (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. (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.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)
  • liver disease
Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)