440 - Children Pain Relief

440 - Children Pain Relief
SPL v8
SPL
SPL Set ID 44c90cbe-8ece-4dd8-9ea5-7f8d6f4c0096
Route
ORAL
Published
Effective Date 2023-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Citric Acid Monohydrate Crospovidone D&c Red No. 27 Aluminum Lake D&c Red No. 30 Dextrates Ethylcellulose, Unspecified Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Mannitol High Density Polyethylene Stearic Acid Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: 44;449 Shape: round Color: purple Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-18
Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Use(s)
  • temporarily relieves minor aches and pains due to:
  • headache
  • sore throat
  • flu
  • toothache
  • the common cold
  • temporarily reduces 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
  • 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.

Directions

this product does not contain directions or complete warnings for adult

use

  • do not give more than directed
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • 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
Weight (lb) Age (yr) Dose (chewable tablets)**
Under 24

 Under 2

 Ask a doctor
24-35

 2-3

 1 tablet
36-47

 4-5

 1 1/2 tablets
48-59

 6-8

 2 tablets
60-71

 9-10

 2 1/2 tablets
72-95

 11

 3 tablets

**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.
  • if your child is allergic to acetaminophen or any of the inactive

    ingredients in this product

Other Information
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  •  store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Questions/comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

Active Ingredient(s)

Acetaminophen 160 mg

Inactive Ingredients

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake,

dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol,

polyethylene, stearic acid, sucralose

Principal Display Panel
Children's Chewable Tablet
When Using This Product

do not exceed recommended dosage.



Ask A Doctor Before Use If

your child has liver disease.

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 (1-800-222-1222) right away. Prompt medical attention

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

Ask A Doctor Or Pharmacist Before Use If

your child is taking the blood thinning drug warfarin.

Structured Label Content

Use(s)
  • temporarily relieves minor aches and pains due to:
  • headache
  • sore throat
  • flu
  • toothache
  • the common cold
  • temporarily reduces fever
Purpose

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
  • 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.

Directions

this product does not contain directions or complete warnings for adult

use

  • do not give more than directed
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • 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
Weight (lb) Age (yr) Dose (chewable tablets)**
Under 24

 Under 2

 Ask a doctor
24-35

 2-3

 1 tablet
36-47

 4-5

 1 1/2 tablets
48-59

 6-8

 2 tablets
60-71

 9-10

 2 1/2 tablets
72-95

 11

 3 tablets

**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.
  • if your child is allergic to acetaminophen or any of the inactive

    ingredients in this product

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  •  store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

Active Ingredient(s) (Active ingredient(s))

Acetaminophen 160 mg

Inactive Ingredients (Inactive ingredients)

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake,

dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol,

polyethylene, stearic acid, sucralose

Principal Display Panel
Children's Chewable Tablet
When Using This Product (When using this product)

do not exceed recommended dosage.



Ask A Doctor Before Use If (Ask a doctor before use if)

your child has liver disease.

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
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Keep Out of Reach of Children (Keep out of reach of children)

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

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

Ask A Doctor Or Pharmacist Before Use If (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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:29.683262 · Updated: 2026-03-14T23:03:33.890868