Acetaminophen by TDS Pharm Co., Ltd ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by TDS Pharm Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Enter section text here

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

• do not take more than directed (see overdose warning)

• 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

• do not use if imprinted safety seal under cap is broken or missing.
• Store at 15° - 30°C (59° - 86°F)
• see end panel for lot number and expiration date
  

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

non-aspirin 50 tablet

Uses

temporarily relieves minor aches and pains due to:

• headache
• muscular aches
• backache
• arthritis
• the common cold
• toothache
• mentrual cramps
• temporarily reduces fever
  

INGREDIENTS AND APPEARANCE

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