Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 851228ea-eaf3-452b-a9ce-8cd244a0eaf3
Route
ORAL
Published
Effective Date 2024-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Butylparaben Carboxymethylcellulose Sodium D&c Red No. 33 Fd&c Blue No. 1 Glycerin High Fructose Corn Syrup Cellulose, Microcrystalline Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-30

Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses
  • temporarily reduces fever
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
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 take more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • use only the enclosed dosing cup designed for use with this product. do not use any other dosing device
  • if needed, repeat dose every 4 hours while symptoms last
  • do not gve more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age

**or as directed by a doctor

Weight (lb) Age (year) Dose (mL)** 
 under 24 under 2 ask a doctor
 24-35 2-3 5 mL
 36-47 4-5 7.5 ml
 48-59 6-8 10 mL
 60-71 9-10 12.5 mL
 72-95 11 15 mL
Do Not Use
  • with any other drug containing acetaminophen (prescription or non-prescription). 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
Product Label
BERKLEY JENSEN (BJ's) Children's Pain Reliever
Other Information
  • each 5 mL contains: sodium 2 mg
  • store between 20-25ºC (68-77ºF)
  • do not refrigerate
  • see bottom panel for lot number and expiration date
Inactive Ingredients

butylparaben, carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

Call 1-800-934-1204 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare To active ingredient in Children's Tylenol® Oral Suspension*

CHILDREN'S PAIN RELIEVER

Ages 2 - 11 Years

ACETAMINOPHEN 160  mg PER 5 mL

ORAL SUSPENSION

PAIN RELIEVER/FEVER REDUCER

ALCOHOL, ASPIRIN & IBUPROFEN FREE

FOR AGES 2-11 YEARS

FL OZ (mL)

GRAPE FLAVOR

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral suspension.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by:

BJ's Wholesale Club

25 Research Drive

Westborough, MA 01581

Questions? 1-800-934-1204

When Using This Product,

do not exceed recommended dosage (see overdose warning)

Stop Use and Ask A Doctor If
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

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. Quick medical attention is critical even if you do not notice any signs or symptoms.

Active Ingredient (in Each 5 Ml)

Acetaminophen 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.


Structured Label Content

Uses
  • temporarily reduces fever
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
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 take more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • use only the enclosed dosing cup designed for use with this product. do not use any other dosing device
  • if needed, repeat dose every 4 hours while symptoms last
  • do not gve more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age

**or as directed by a doctor

Weight (lb) Age (year) Dose (mL)** 
 under 24 under 2 ask a doctor
 24-35 2-3 5 mL
 36-47 4-5 7.5 ml
 48-59 6-8 10 mL
 60-71 9-10 12.5 mL
 72-95 11 15 mL
Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or non-prescription). 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
Product Label
BERKLEY JENSEN (BJ's) Children's Pain Reliever
Other Information (Other information)
  • each 5 mL contains: sodium 2 mg
  • store between 20-25ºC (68-77ºF)
  • do not refrigerate
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

butylparaben, carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1-800-934-1204 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare To active ingredient in Children's Tylenol® Oral Suspension*

CHILDREN'S PAIN RELIEVER

Ages 2 - 11 Years

ACETAMINOPHEN 160  mg PER 5 mL

ORAL SUSPENSION

PAIN RELIEVER/FEVER REDUCER

ALCOHOL, ASPIRIN & IBUPROFEN FREE

FOR AGES 2-11 YEARS

FL OZ (mL)

GRAPE FLAVOR

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral suspension.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by:

BJ's Wholesale Club

25 Research Drive

Westborough, MA 01581

Questions? 1-800-934-1204

When Using This Product, (When using this product,)

do not exceed recommended dosage (see overdose warning)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

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. Quick medical attention is critical even if you do not notice any signs or symptoms.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Acetaminophen 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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)