ACETAMINOPHEN - acetaminophen tablet 
TDS Pharm Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients (in each tablet)

                       

Acetaminophen 500mg


Purpose

Pain Reliever/fever reducer

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 maxium 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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

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 use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
These could be sign of a serious condition

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

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Overdose warning:

Taking more than the recommended dose(overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions


adults and children 12 years and over
  • take 2 tablets every 4 to 6 house as needed
  • do not take more than 8 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor


children under 12 years
do not use this adult Extra Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
                      

Other Information

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

non-aspirin 50 tabletimage of carton label

Uses

temporarily relieves minor aches and pains due to:

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42912-0153
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 500 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 13mm
Flavor Imprint Code A500
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42912-0153-6 1 in 1 BOX
1 50 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 08/01/2010
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42912-0152
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 500 mg
Product Characteristics
Color white Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code A500
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42912-0152-7 1 in 1 BOX
1 40 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 07/15/2010
Labeler - TDS Pharm Co., Ltd (689951176)
Registrant - TDS Pharm Co., Ltd (689951176)
Establishment
Name Address ID/FEI Business Operations
TDS Pharm Co., Ltd 689951176 manufacture

Revised: 6/2010
Document Id: 896e0b77-09de-4832-9c3d-d273005e5b43
Set id: c3b408ff-f47b-4fee-ade5-5db6e25f4ee0
Version: 1
Effective Time: 20100630
 
TDS Pharm Co., Ltd