Major 44-452

Major 44-452
SPL v6
SPL
SPL Set ID 69c90cc8-846a-42cf-933a-108671689e8f
Route
ORAL
Published
Effective Date 2024-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (80 mg)
Inactive Ingredients
Citric Acid Monohydrate Crospovidone D&c Red No. 27 Aluminum Lake D&c Red No. 30 Dextrose Monohydrate Ethylcellulose, Unspecified Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Mannitol High Density Polyethylene Stearic Acid Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: 44;452 Shape: round Color: purple Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-12-06

Description

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

How Supplied

Acetaminophen 80 mg Chewable Tablets NDC: 71335-1186-1: 30 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

Purpose

Pain reliever/fever reducer

How Supplied

Acetaminophen 80 mg Chewable Tablets

  • NDC: 71335-1186-1: 30 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Acetaminophen 80 mg

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • sore throat
    • the common cold
    • flu
  • temporarily reduces fever
Section 51945-4

Acetaminophen 80 mg Chewable Tablets

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 or crush tablets completely before swallowing; do not swallow tablets whole
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

Weight (lb) Age (yr) Dose

(chewable tablets)*
Under 24 Under 2 Ask a doctor
24-35 2-3 2 tablets
36-47 4-5 3 tablets
48-59 6-8 4 tablets
60-71 9-10 5 tablets
72-95 11 6 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
  • avoid high humidity

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
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

Questions Or Comments?

(800) 616-2471

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.

In case of overdose, get medical help or contact a Poison Control Center 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 Before Use If Your Child Has

liver disease.

Active Ingredient (in Each Chewable Tablet)

Acetaminophen 80 mg

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • sore throat
    • the common cold
    • flu
  • temporarily reduces fever
Section 51945-4 (51945-4)

Acetaminophen 80 mg Chewable Tablets

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 or crush tablets completely before swallowing; do not swallow tablets whole
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

Weight (lb) Age (yr) Dose

(chewable tablets)*
Under 24 Under 2 Ask a doctor
24-35 2-3 2 tablets
36-47 4-5 3 tablets
48-59 6-8 4 tablets
60-71 9-10 5 tablets
72-95 11 6 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
How Supplied (HOW SUPPLIED)

Acetaminophen 80 mg Chewable Tablets

  • NDC: 71335-1186-1: 30 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (Other information)
  • avoid high humidity

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
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

Questions Or Comments? (Questions or comments?)

(800) 616-2471

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.)

In case of overdose, get medical help or contact a Poison Control Center 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 Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease.

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

Acetaminophen 80 mg

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

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