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PHYSICIANSCARE NON ASPIRIN  EXTRA STRENGTH - acetaminophen tablet, film coated 
Acme United Corporation

PhysiciansCare Non Aspirin Extra Strength (Acetaminophen)

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
    * muscular aches
    * minor arthritis pain
    * common cold
    * toothache
    * 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 alcholic dinks 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 thinnning drug warfarin

Stop use and ask a doctor if

    * symptoms do not improve
    * new symptoms occur
    * pain of fever persists or gets worse
    * redness or swelling is present

Keep out of the 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 two tablets every 4 to 6 hous as needed.  Do not take more than 8 tablets in 24 hours.

Children under 12 years:
  Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

    * store at room temperature 59-86 F (15-30 C)
    * tamper-evident seald packets
    * do not use any open or torn packets

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.

*may contain

Questions or comments?  1-800-835-2263

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PHYSICIANSCARE NON ASPIRIN   EXTRA STRENGTH
acetaminophen  tablet, film coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0924-0128 (47682-128)
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
HYPROMELLOSES  
POVIDONE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STARCH, CORN  
STEARIC ACID  
CELLULOSE, MICROCRYSTALLINE  
MALTODEXTRIN  
POLYETHYLENE GLYCOL 2000  
Product Characteristics
Color white (white) Score no score
Shape ROUND (ROUND) Size 12mm
Flavor Imprint Code FR;33
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0924-0128-01 50 PACKET In 1 CARTON contains a PACKET
1 2 TABLET In 1 PACKET This package is contained within the CARTON (0924-0128-01)
2 0924-0128-02 125 PACKET In 1 CARTON contains a PACKET
2 2 TABLET In 1 PACKET This package is contained within the CARTON (0924-0128-02)
3 0924-0128-03 10 PACKET In 1 CARTON contains a PACKET
3 2 TABLET In 1 PACKET This package is contained within the CARTON (0924-0128-03)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 01/20/2012

Labeler - Acme United Corporation (001180207)
Establishment
Name Address ID/FEI Operations
Acme United Corporation 045924339 relabel, repack
Establishment
Name Address ID/FEI Operations
Acme United Corporation Pac-Kit Safety Division 883538258 label, repack
Revised: 01/2012Acme United Corporation