ACETAMINOPHEN- acetaminophen tablet 
NuCare Pharmaceuticals,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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gc204

Active Ingredients

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:

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

Do not use

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

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. In case of overdose, get medical
help or contact a Poison Control Center 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

Other Information

Inactive Ingredients

povidone, sodium starch glycolate, starch, stearic acid.

Questions or comments?

1-800-540-3765

pdp

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-2821(NDC:57896-204)
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 (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeROUND (Round) Size12mm
FlavorImprint Code AZ011
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-2821-220 in 1 BOTTLE; Type 0: Not a Combination Product08/26/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/01/2018
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300repack(68071-2821)

Revised: 8/2022
Document Id: e72bf35b-acca-3562-e053-2995a90aeff3
Set id: e72bf35b-acc9-3562-e053-2995a90aeff3
Version: 1
Effective Time: 20220826
 
NuCare Pharmaceuticals,Inc.