ACETAMINOPHEN- acetaminophen caplet, 500 mg extra strength tablet 
HealthRight Products, LLC

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 USP 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 tablets in 24 hours, which is the maximum daily amount 

  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Stop use and ask a doctor if

  • You are suffering from any liver disease
  • you are taking the blood thinning drug warfarin
  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

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

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Dosage

Adults and children over 12 years of age, Take 2 caplets every 6 hours while symptoms last, do not take more than 6 caplets in 24 hours, unless directed by a doctor. 

Children under 12
, ask a doctor. 

Storage

Inactive ingredients

Micro crystalline Cellulose, Corn Starch, Sodium Starch Glycolate Type A, Sodium Lauryl sulfate, Sodium Methyl Paraben, Magnesium Stearate, Talc, Croscarmellose Sodium and polyvinyl pyrrolidone K-30

Information

Tamper Evident: Do not use if safety seal under cap is broken or missing

Swallow whole, do not crush, chew, split or dissolve

PRINCIPAL DISPLAY PANEL - 200 CT 

Acetaminophen Caplet, 500 mg

Pain Reliever - Fever Reducer

image description

ACETAMINOPHEN 
acetaminophen caplet, 500 mg extra strength tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77800-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
Colorwhite (White to Off-White) Score2 pieces
ShapeCAPSULE (Caplet Shape) Size18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77800-100-01200 in 1 BOTTLE; Type 0: Not a Combination Product07/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/24/2020
Labeler - HealthRight Products, LLC (831577916)

Revised: 7/2020
Document Id: 8b16d62b-4365-490c-a9c3-29f77f858916
Set id: 8f78bece-25fa-4a42-90f0-c899e6644d54
Version: 2
Effective Time: 20200728
 
HealthRight Products, LLC