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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gc101 (104)

Active Ingredients

Acetaminophen 325 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: • skin reddening
• blisters • rash 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.

Package Label

pdp

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-2481(NDC:57896-104)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (WHITE) Score2 pieces
ShapeROUND (Round) Size10mm
FlavorImprint Code 44;104
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-2481-550 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2021
2NDC:68071-2481-440 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2021
3NDC:68071-2481-330 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2021
4NDC:68071-2481-220 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2021
5NDC:68071-2481-725 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/01/2020
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300repack(68071-2481)

Revised: 9/2023
Document Id: 05bd9ef2-fe59-08b4-e063-6394a90a58ba
Set id: c7cc3f87-3fbe-430a-e053-2a95a90a4e79
Version: 3
Effective Time: 20230919
 
NuCare Pharmaceuticals,Inc.