SPL v2
SPL
SPL Set ID 30756257-f748-4a5d-b031-dd267d0f91ad
Route
ORAL
Published
Effective Date 2023-11-24
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 2022-06-18
Description

Active ingredient (in each chewable tablet) Acetaminophen USP 160 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each chewable tablet) Acetaminophen USP 160 mg

Uses
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • soar 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)
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb)

Age (yr)

Dose (tablets)*

under 24

under 2 years

ask a doctor

24 to 35 lbs

2 to 3 years

1 tablet

36 to 47 lbs

4 to 5 years

1½ tablets

48 to 59 lbs

6 to 8 years

2 tablets

60 to 71 lbs

9 to 10 years

2½ tablets

72 to 95 lbs

11 years

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
Drug Facts

Active ingredient (in each chewable tablet)



Acetaminophen USP 160 mg

Other Information
  • store between 20° to 25°C (68° to 77°F). Avoid high humidity. Protect from light.
  • 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

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: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.

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 (48 Chewable Tablets Blister Carton Label)

Healthy Living TM

Ages 2-11               DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN



CHILDREN’S PAIN RELIEF

acetaminophen chewable tablets 160 mg



Pain Reliever / Fever Reducer



160 mg

per Tablet



Pain + Fever



Chewables - Chew or crush

tablets completely before swallowing



Compare

to the active

ingredient in

Children's

Tylenol ®

Chewables



• Aspirin Free              

• Ibuprofen Free



Bubble Gum Flavor                            Actual Size

                                                   48 Chewable Tablets

                                                      160 mg each







Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • soar 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)
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb)

Age (yr)

Dose (tablets)*

under 24

under 2 years

ask a doctor

24 to 35 lbs

2 to 3 years

1 tablet

36 to 47 lbs

4 to 5 years

1½ tablets

48 to 59 lbs

6 to 8 years

2 tablets

60 to 71 lbs

9 to 10 years

2½ tablets

72 to 95 lbs

11 years

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
Drug Facts

Active ingredient (in each chewable tablet)



Acetaminophen USP 160 mg

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F). Avoid high humidity. Protect from light.
  • 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? (Questions or comments?)

Call 1-855-274-4122

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: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.

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 (48 Chewable Tablets Blister Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 160 mg (48 Chewable Tablets Blister Carton Label))

Healthy Living TM

Ages 2-11               DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN



CHILDREN’S PAIN RELIEF

acetaminophen chewable tablets 160 mg



Pain Reliever / Fever Reducer



160 mg

per Tablet



Pain + Fever



Chewables - Chew or crush

tablets completely before swallowing



Compare

to the active

ingredient in

Children's

Tylenol ®

Chewables



• Aspirin Free              

• Ibuprofen Free



Bubble Gum Flavor                            Actual Size

                                                   48 Chewable Tablets

                                                      160 mg each







Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:24.430710 · Updated: 2026-03-14T23:01:55.379030