FDA Label for Henry Schein Acetaminophen

View Indications, Usage & Precautions

Henry Schein Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Henry Schein, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)



Acetaminophen 325 mg


Purpose



Pain reliever/fever reducer


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.


Other



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

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

Ask A Doctor Before Use If You Have



  • liver disease

Ask A Doctor Or Pharmacist Before Use If



  • you are taking the blood thinning drug warfarin

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

Otc - Pregnancy Or Breast Feeding



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


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.


Directions



  • do not use more than directed

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.


Children Under 12 Years:



Do not give to children under 12 years of age.


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


Otc - Questions



Questions or comments? 1-800-472-4346


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®

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900-4689

Acetaminophen 325 mg

250 Packets/2 Tablets


* Please review the disclaimer below.