ACETAMINOPHEN 500 MG- acetaminophen tablet 
NUVICARE LLC

----------

Extra Strength Pain Relief ACETAMINOPHEN 500 mg

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 (718) 337-8733 or visit: support@nuvicare.com 

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.

PL0201-00 NC-Pain Relief ES (Acetaminophen)-100ct

ACETAMINOPHEN 500 MG 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84324-003
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
ShapecapsuleSize17mm
FlavorImprint Code P500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84324-003-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/17/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/17/2024
Labeler - NUVICARE LLC (119257565)
Registrant - NUVICARE LLC (119257565)
Establishment
NameAddressID/FEIBusiness Operations
TRUECARE BIOMEDIX650526341manufacture(84324-003)
Establishment
NameAddressID/FEIBusiness Operations
MAK Pharma USA109960731pack(84324-003)

Revised: 7/2024
Document Id: edd0885f-2866-4059-96f6-3109edffd9e3
Set id: 95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e
Version: 1
Effective Time: 20240716
 
NUVICARE LLC