ACETAMINOPHEN TABLETS, 500 MG EXTRA STRENGTH- acetaminophen tablet 
We Care Distributors Inc.

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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 Acetaminophen 500 mg Extra Strength

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

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

Other information

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

PRINCIPAL DISPLAY PANEL - 50 Pouch Box

ACETAMINOPHEN TABLETS, 500 MG EXTRA STRENGTH 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code BH
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70005-006-5050 in 1 BOX
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:70005-006-2525 in 1 BOX
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:70005-006-022 in 1 POUCH
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/08/2016
Labeler - We Care Distributors Inc. (079832998)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceutical Ltd.915664486manufacture(70005-006)

Revised: 2/2016
Document Id: af3f90ed-b08c-450e-80e0-2a477a5ca095
Set id: a180dcf9-1224-4425-872d-a341f72f9b72
Version: 2
Effective Time: 20160208
 
We Care Distributors Inc.