ACETAMINOPHEN- acetaminophen tablet 
Safetec of America, 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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Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

Allergy alert: acetaminophen may case Severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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

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 last 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

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

adults and children 12 years and over

children under 12 years

ask a doctor

Other information

Inactive ingredients

hypromellose, polyethylene glycol, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions or comments?

Call toll free: 1-800-456-7077

Principal Display Panel – Pouch Label

DO NOT USE IF POUCH IS TORN OR DAMAGED

Safetec
of America, Inc.

Manufactured for Safetec of America, Inc.
Buffalo NY 14215

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

Principal Display Panel – Pouch Label
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4406
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
hypromellose 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
povidone k30 (UNII: U725QWY32X)  
starch, corn (UNII: O8232NY3SJ)  
sodium starch glycolate type a potato (UNII: 5856J3G2A2)  
stearic acid (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeOVAL (OVAL) Size17mm
FlavorImprint Code 500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-4406-02 in 1 POUCH; Type 0: Not a Combination Product12/30/2019
2NDC:61010-4406-150 in 1 BOX12/30/2019
2NDC:61010-4406-02 in 1 POUCH; Type 0: Not a Combination Product
3NDC:61010-4406-2100 in 1 BOX12/30/2019
3NDC:61010-4406-02 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/30/2019
Labeler - Safetec of America, Inc. (874965262)

Revised: 12/2019
Document Id: 31cf574b-6ae9-40dc-a823-8b48242910ca
Set id: 67870e7a-88fd-43cf-97e8-cbf546ad4f3f
Version: 2
Effective Time: 20191230
 
Safetec of America, Inc.