ACETAMINOPHEN 500 MG- acetaminophen tablet 
Pioneer Life Sciences, 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.

----------

Extra Strength ACETAMINOPHEN 500 MG Caplet

Drug Facts

Active ingredient (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

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

Do not use

Ask a doctor before use if you have

Ask a doctor/pharmacist before use if you are

Stop use and ask a doctor if

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 (1-800-222-1222) 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

Adults and  children 12 years and over:

Children under 12 Years

Other information

Inactive ingredients

Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone k30, Purified water, Sodium Starch Glycolate, Starch Corn, Talc, Titanium Dioxide

Questions or comments?

call 1-732-698-5070 Monday through friday 9 AM to 5 pm EST or www.pioneerlifesciences.com

TAMPER EVIDENT: Do not use if imprinted saftey seal under cap is broken or missing.

This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tyleno® Extra Strength Caplets.

Distributed by:

GenCare Consumer Products LLC

40E Cotters Ln Suite A,

East Brunswick, NJ 08816

NDC 72090-008-30 (300 tablets in a bottle)

label-300ct

ACETAMINOPHEN 500 MG 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-008
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE K30 (UNII: U725QWY32X)  
WATER (UNII: 059QF0KO0R)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapecapsuleSize18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72090-008-30300 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/11/2023
Labeler - Pioneer Life Sciences, LLC (014092742)
Registrant - Pioneer Life Sciences, LLC (014092742)

Revised: 5/2023
Document Id: a36f81c9-7bdd-4acd-891b-703427d0c20c
Set id: 11e6ec2a-5171-4496-a15f-6ff744bd1f2f
Version: 1
Effective Time: 20230511
 
Pioneer Life Sciences, LLC