Henry Schein®

Henry Schein®
SPL v10
SPL
SPL Set ID f43f72de-ff79-4c7e-bd1e-3f0c4c3872fa
Route
ORAL
Published
Effective Date 2018-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Hypromelloses Polyethylene Glycol Povidone Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AZ;234 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-12-30

Description

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325 mg

Uses

For the temporary relief of minor aches and pains associated with

  • headache
  • common cold
  • muscular aches
  • toothache
  • minor arthritis pain
  • menstrual cramps

For the reduction of fever.

Section 42229-5

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Section 53413-1

Questions or comments? 1-800-472-4346

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • do not use more than directed
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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
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.

Other Information
  • store at room temperature 59°-86°F (15°-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients

corn starch, hypromellose, polyethylene glycol, povidone*, pregelatinized starch, sodium starch glycolate*, stearic acid, titanium dioxide

Children Under 12 Years:

Do not give to children under 12 years of age.

Keep Out of Reach of Children.

In case of accidental 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.

Stop Using and Ask A Doctor If
  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present
Active Ingredient (in Each Tablet)

Acetaminophen 325 mg

Ask A Doctor Before Use If You Have
  • liver disease
Henry Schein Actaminophen 325 Mg Label

Henry Schein®

Acetaminophen

For the temporary relief of minor aches and pains

associated with the headache, muscular aches, minor arthritis pain,

common cold, toothache, menstrual cramps and for the reduction of fever.

Henry Schein Seal of Excellence®

Pull to Open

Reorder

900-4689

Acetaminophen 325 mg

250 Packets/2 Tablets

Adults and Children:(12 Years and Older)

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

Ask A Doctor Or Pharmacist Before Use If
  • you are taking the blood thinning drug warfarin

Structured Label Content

Uses

For the temporary relief of minor aches and pains associated with

  • headache
  • common cold
  • muscular aches
  • toothache
  • minor arthritis pain
  • menstrual cramps

For the reduction of fever.

Section 42229-5 (42229-5)

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Section 53413-1 (53413-1)

Questions or comments? 1-800-472-4346

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Pain reliever/fever reducer

Directions
  • do not use more than directed
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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
Allergy Alert: (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.

Other Information (Other information)
  • store at room temperature 59°-86°F (15°-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, polyethylene glycol, povidone*, pregelatinized starch, sodium starch glycolate*, stearic acid, titanium dioxide

Children Under 12 Years: (Children under 12 years:)

Do not give to children under 12 years of age.

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

In case of accidental 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.

Stop Using and Ask A Doctor If (Stop using and ask a doctor if)
  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Acetaminophen 325 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
Henry Schein Actaminophen 325 Mg Label (Henry Schein Actaminophen 325 mg Label)

Henry Schein®

Acetaminophen

For the temporary relief of minor aches and pains

associated with the headache, muscular aches, minor arthritis pain,

common cold, toothache, menstrual cramps and for the reduction of fever.

Henry Schein Seal of Excellence®

Pull to Open

Reorder

900-4689

Acetaminophen 325 mg

250 Packets/2 Tablets

Adults and Children:(12 Years and Older) (Adults and children:(12 years and older))

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • you are taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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