ACETAMINOPHEN 500 MG- acetaminophen tablet 
NUVICARE LLC

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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

Pregelatinzed starch, Polyvinyl pyrrolidone, stearic acid powder, microcrystalline cellulose, magnesium stearate, Hypromellose-5, Hypromellose-15, polyethlene glycol 400, titanium dioxide, talc

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.

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ACETAMINOPHEN 500 MG 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84324-021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorwhiteScoreno score
ShapecapsuleSize17mm
FlavorImprint Code S500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84324-021-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/01/2025
Labeler - NUVICARE LLC (119257565)

Revised: 12/2024
Document Id: c66390b0-ecfe-4c3a-b954-d0d462efaf50
Set id: 591ee107-e953-4982-b75f-13a0afd7c4ae
Version: 1
Effective Time: 20241225
 
NUVICARE LLC