Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 49a740ec-8ed4-4c76-b2d0-c13651bafa5e
Route
ORAL
Published
Effective Date 2025-09-18
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Silicon Dioxide Copovidone K25-31 Crospovidone (120 .mu.m) D&c Red No. 27 D&c Red No. 30 Dextrose Monohydrate Ethylcellulose (4 Mpa.s) Magnesium Stearate Mannitol Sodium Starch Glycolate Type A Potato Stearic Acid Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: F8 Shape: round Color: pink Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-09-13
Description

Acetaminophen USP 160 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen USP 160 mg

Uses


  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
  • 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 (see overdose warning)
  • find 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


Weight (lb)

Age (yr)

Dose (tablets)*

* or as directed by a doctor
under 24

 under 2 years

 ask a doctor
24-35

 2-3 years

 1 tablet
36-47

 4-5 years

 1½ tablets
48-59

 6-8 years

 2 tablets
60-71

 9-10 years

 2½ tablets
72-95

 11 years

 3 tablets


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


  • store at 20° to 25°C (68° to 77°F). Avoid high humidity.
  • Tamper Evident: Do not use if carton is open or if printed seal on blister is broken or missing.
Inactive Ingredients

citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.



Questions or comments?



Call 1-855-274-4122





* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Chewables.



DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN





Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

When Using This Product

do not exceed recommended dosage.

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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Active Ingredient (in Each Tablet)

Acetaminophen USP 160 mg

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.

Package Label Principal Display Panel  160 Mg (24 Chewable Tablets)

NDC 58602-766-76

Ages 2-11

Children's Pain Relief

Acetaminophen 160 mg

Pain reliever/Fever reducer

 

  • Aspirin Free                         
  • Ibuprofen Free

 



Bubblegum Flavor



Compare to the active ingredient in

Children's Tylenol® Chewables*

24

Chewable Tablets







Structured Label Content

Uses


  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
  • 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 (see overdose warning)
  • find 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


Weight (lb)

Age (yr)

Dose (tablets)*

* or as directed by a doctor
under 24

 under 2 years

 ask a doctor
24-35

 2-3 years

 1 tablet
36-47

 4-5 years

 1½ tablets
48-59

 6-8 years

 2 tablets
60-71

 9-10 years

 2½ tablets
72-95

 11 years

 3 tablets


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)


  • store at 20° to 25°C (68° to 77°F). Avoid high humidity.
  • Tamper Evident: Do not use if carton is open or if printed seal on blister is broken or missing.
Inactive Ingredients (Inactive ingredients)

citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.



Questions or comments?



Call 1-855-274-4122





* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Chewables.



DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN





Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

When Using This Product (When using this product)

do not exceed recommended dosage.

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.)

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Acetaminophen USP 160 mg

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.

Package Label Principal Display Panel  160 Mg (24 Chewable Tablets) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 mg (24 Chewable Tablets))

NDC 58602-766-76

Ages 2-11

Children's Pain Relief

Acetaminophen 160 mg

Pain reliever/Fever reducer

 

  • Aspirin Free                         
  • Ibuprofen Free

 



Bubblegum Flavor



Compare to the active ingredient in

Children's Tylenol® Chewables*

24

Chewable Tablets







Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:03.503226 · Updated: 2026-03-14T23:10:13.362427