ACETAMINOPHEN TABLETS, 500 MG EXTRA STRENGTH- acetaminophen tablet

Acetaminophen Tablets, 500 mg Extra Strength by

Drug Labeling and Warnings

Acetaminophen Tablets, 500 mg Extra Strength by is a Otc medication manufactured, distributed, or labeled by We Care Distributors Inc., Elysium Pharmaceutical Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Important: Read all product information before using. Keep this box for important information.

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Use

• temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
• temporarily reduces fever

Warnings

Allergy alert: Acetaminophen may cause severe skin reaction. Symptoms may include:

• skin reddening 
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

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

• more than 4,000 mg of acetaminophen in 24 hours
• 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

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

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

Keep out of reach of children.

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. (1-800-222-1222) 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 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
• children under 12 years: do not use

Other information

• store between 20-25˚C (68-77˚F)
• do not use if pouch is torn or open
• see side panel for lot number and expiration date

Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose , pregelatinized starch, polyethylene glycol, polyvinyl pyrrolidinone, stearic acid, talc, titanium dioxide

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

PRINCIPAL DISPLAY PANEL - 25 Pouch Box

See New Warnings Information & Directions

Compate to the Active Ingredients in
Tylenol® Extra Strength *

Acetaminophen Tablets, 500 mg
Pain Reliever - Fever Reducer

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN TABLETS, 500 MG EXTRA STRENGTH 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70005-006
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
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	BH
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70005-006-50	50 in 1 BOX
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 70005-006-25	25 in 1 BOX
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 70005-006-02	2 in 1 POUCH
3		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/08/2016

Labeler - We Care Distributors Inc. (079832998)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceutical Ltd.		915664486	manufacture(70005-006)