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HENRY SCHEIN ACETAMINOPHEN - acetaminophen tablet, film coated 
Henry Schein, Inc.

Henry Schein®
Extra Strength
Acetaminophen

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

For the temporary relief of minor aches and pains associated with

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

For the reduction of fever.

Warnings

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

  • more than 8 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

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.

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

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 8 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

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

Questions or comments? 1-800-472-4346

175R Henry Schein XS Acetaminophen Label

NDC #0404-0716-13

Henry Schein®

Extra Strength

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®

Reorder

900-4690

See new warnings information

Acetaminophen 500 mg

250 Packets/2 Tablets

Henry Schein XS Acetaminophen Label

HENRY SCHEIN ACETAMINOPHEN 
acetaminophen  tablet, film coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0404-0716
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE  
POVIDONE  
STARCH, CORN  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color white (white) Score no score
Shape ROUND (ROUND) Size 12mm
Flavor Imprint Code AZ;235
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0404-0716-99 2 TABLET In 1 PACKET None
2 0404-0716-13 500 TABLET In 1 BOX, UNIT-DOSE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 12/30/2008

Labeler - Henry Schein, Inc. (012430880)
Revised: 03/2010Henry Schein, Inc.