Acetaminophen by Kareway Product, Inc. ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. 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

Uses

temporarily relieves minor aches and pains due to:

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

Package label

Non-Aspirin Pain Relief Extra Strength 40 caplates

Package Label

Non-Aspirin Pain Relief Extra Strength 40 tablets

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0153
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
ICODEXTRIN (UNII: 2NX48Z0A9G)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)

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: 67510-0153-6	1 in 1 BOX
1		50 in 1 BOTTLE
2	NDC: 67510-0153-4	1 in 1 BOX
2		40 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	08/11/2011

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0152
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
ICODEXTRIN (UNII: 2NX48Z0A9G)
STARCH, CORN (UNII: O8232NY3SJ)
LAURYL SULFATE (UNII: DIQ16UC154)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)

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: 67510-0152-7	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	08/11/2011

Labeler - Kareway Product, Inc. (121840057)