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ACETAMINOPHEN 500 MG

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Reliable 1 Laboratories LLC
NDC Code: 69618-011

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.

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

NDC 69618-011-01

Extra Strength

Acetaminophen USP 500 mg

PAIN RELIEVER

FEVER REDUCER

100 TABLETS

*Compare to Active Ingredient in Extra Strength Tylenol®

ACETAMINOPHEN 500 MG 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-011
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A POTATO 
POVIDONE 
STARCH, PREGELATINIZED CORN 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint CodeAP;013
Contains    
Packaging
#Item CodePackage Description
1NDC:69618-011-01100 TABLET in 1 BOTTLE, PLASTIC
2NDC:69618-011-101000 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/01/2015
Labeler - Reliable 1 Laboratories LLC (079718111)

Revised: 10/2015
 
Reliable 1 Laboratories LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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