ACETAMINOPHEN 500 MG TABLET

ACETAMINOPHEN 500 MG by

Drug Labeling and Warnings

ACETAMINOPHEN 500 MG by is a Otc medication manufactured, distributed, or labeled by Quality Care Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETAMINOPHEN 500 MG- acetaminophen tablet 
Quality Care Products, LLC

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ACETAMINOPHEN 500 MG TABLET

Drug Facts

Active ingredient (in each tablet)

Acetaminophen USP, 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours which is the maximum daily amount
  • 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 symptoms 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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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

do not take more than directed (see overdose warning)

adults & children 12 years and over:

  • take 1 tablet every 3-4 hours or 2 tablets every 6 hours while symptoms last
  • do not take more than 8 tablets in 24 hours

children under 12 years: do not use

Other information

  • store at 15º to 30ºC (59º to 86ºF)

Inactive ingredients

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

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark TYLENOL®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

image description

ACETAMINOPHEN 500 MG 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55700-946(NDC: 69618-011)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code AP;013
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55700-946-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/07/202101/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01310/07/202101/31/2024
Labeler - Quality Care Products, LLC (831276758)
Establishment
NameAddressID/FEIBusiness Operations
Quality Care Products, LLC831276758repack(55700-946)

Revised: 12/2023
Document Id: 00942461-1909-49a6-83d0-7c5b6a3b744c
Set id: 729f4669-ba6e-435e-ade3-e3fe76718b29
Version: 2
Effective Time: 20231213