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pain reliever extra strength by Walgreens

Medically reviewed on December 6, 2017

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 500mg
Labeler: Walgreens
NDC Code: 0363-0711

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.

DRUG FACTS

Active ingredient (in each capsule)

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

Uses
  • temporarily relieves minor aches and pains due to
  • headache
  • the common cold
  • 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

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.
  • 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 (1-800-222-1222) 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 6 capsules in any 24-hour period
  • do not take more than directed (see Overdose warning)
  • adults and children 12 years and over
    • take 2 capsules every 6 hours while symptoms  last
    • do not take more than 10 days unless directed by a doctor
  • children under 12 years: do not use

Other information
  • each capsule contains: sodium 9 mg
  • do not chew, crush, or dissolve capsule before swallowing
  • store between 15-30ºC (59-86ºF)

Inactive ingredients

FD&C red #40, gelatin, glycerin, polyethylene glycol, potassium hydroxide, povidone, propylene glycol, purified water,sodium hydroxide, sorbitan, sorbitol, titanium dioxide

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

EXTRA STRENGTH

Pain Reliever

Acetaminophen 500 mg / Pain Reliever / Fever Reducer

SOFTGELS*

(*Liquid-Filled Capsules)

Compare to Tylenol® Extra Strength active ingredient≠≠

≠≠This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength.

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

DISTRIBUTED BY: WALGREENS CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Product Label

WALGREENS Extra Strength Pain Reliever

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0711
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
POVIDONE 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
TITANIUM DIOXIDE 
FD&C RED NO. 40 
POTASSIUM HYDROXIDE 
SODIUM HYDROXIDE 
SORBITAN 
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code710
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0711-01100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/30/2016
Labeler - Walgreens (008965063)

 
Walgreens

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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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