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Pain Relief Extra Strength by Chain Drug Marketing Association

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: Chain Drug Marketing Association
NDC Code: 63868-084

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.

Quality Choice Pain Relief Extra Strength Caplets - 2014-1027

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • 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
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

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

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 and children 12 years and over
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 years
  • ask a doctor

Other information
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information

Inactive ingredients

hypromellose, mineral oil, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

NDC 63868-084-50

QUALITY CHOICE

†Compare to the Active Ingredient in TYLENOL® Extra Strength Caplets

Extra Strength

Pain Relief

Pain Reliever / Fever Reducer

Acetaminophen, 500 mg

50 Caplets – 500 mg each

PAIN RELIEF   EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-084
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONES 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint CodeM2A4;57344
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-084-241 BOTTLE, PLASTIC in 1 CARTON
124 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:63868-084-501 BOTTLE, PLASTIC in 1 CARTON
250 TABLET, COATED in 1 BOTTLE, PLASTIC
3NDC:63868-084-101 BOTTLE, PLASTIC in 1 CARTON
3100 TABLET, COATED in 1 BOTTLE, PLASTIC
4NDC:63868-084-05500 TABLET, COATED in 1 BOTTLE, PLASTIC
5NDC:63868-084-202 BOTTLE, PLASTIC in 1 CARTON
5100 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/13/2014
Labeler - Chain Drug Marketing Association (011920774)

Revised: 10/2014
 
Chain Drug Marketing Association

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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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