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Extra Strength Pain Relief by Chain Drug Marketing Association Inc.

Medically reviewed on July 23, 2018

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 500mg
Labeler: Chain Drug Marketing Association Inc.
NDC Code: 63868-863

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.

Extra Strength Pain Relief

Drug Facts

Active ingredient (in each softgel)

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 of age and over

  • take 2 softgels every 6 hours while symptoms last
  • do not take more than 6 softgels 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 of age

     ask a doctor

Other information
  • store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Questions or comments?

Call: 248-449-9300

PRINCIPAL DISPLAY PANEL

Extra Strength Pain Relief

Acetaminophen, 500mg 40 Liquid Gels

NDC 63868-863-40

*Compare to the active ingredient in TYLENOL® Extra Strength

Extra Strength Pain Relief

Acetaminophen, 500mg 80 Liquid Gels

NDC 63868-863-80

*Compare to the active ingredient in TYLENOL® Extra Strength

EXTRA STRENGTH PAIN RELIEF 
acetaminophen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-863
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
Colorred (clear) Scoreno score
Shapecapsule (oblong) Size27mm
FlavorImprint CodePC24
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-863-4040 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:63868-863-8080 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/22/2016
Labeler - Chain Drug Marketing Association Inc. (011920774)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(63868-863), analysis(63868-863)

 
Chain Drug Marketing Association Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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