EXTRA STRENGTH ACETAMINOPHEN- acetaminophen tablet 
NuCare Pharmaceuticals,Inc.

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Acetaminophen

Active ingredient

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

  • temporarily relieves minor aches and pains
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The
maximum daily dose of this product is 6 caplets in 24 hours.
Severe liver damage may occur if you take:

  • more than 8 caplets (4,000 mg of acetaminophen) in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptom occur
  • redness or swelling is present

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.

Directions

  • do not take more than directed
  • adults and children 12 years and over: take 1-2 caplets
    every 4-6 hours, as needed. Do not take more than 6
    caplets in 24 hours, unless directed by a doctor.
  • children under 12 years: do not use

Other Information

  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive ingredients

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Package label

pdp

EXTRA STRENGTH ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-5229(NDC:57896-222)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeCAPSULE (Capsule) Size17mm
FlavorImprint Code AZ328
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-5229-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01308/01/201812/31/2021
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-5229)

Revised: 6/2024
 
NuCare Pharmaceuticals,Inc.