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Extra Strength Headache Relief

Medically reviewed on June 7, 2017

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 250mg, ASPIRIN 250mg, CAFFEINE 651
Labeler: Healthlife of USA
NDC Code: 69517-105

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 Headache Relief

Drug Facts

Purpose

Pain reliever, Pain reliever aid

Active Ingredient (in each caplet)

Acetaminophen 250mg

Aspirin 250mg

Caffeine 65mg

Uses
  • Temporarily relieves minor aches and pains due to:
  • headache
  • a cold
  • arthritis
  • muscular aches
  • sinusitis 
  • toothache
  • premenstrual and menstrual cramps

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behaviour with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

  • hives
  • shock
  • facial swelling
  • asthma (wheezing)

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

  • more than 8 Tablets 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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: 

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, food, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use
  • if you ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/ fever reducer
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure wheather a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if 
  • you have liver disease
  • stomach bleeding warning applies to you 
  • you have a history of stomach problems, such as heartburn 
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are
  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away.
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • painful area is red or swollen

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

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 use more than directed
  • Drink a full glass of water with each dose
  • Adults and children 12 years and over
  • Take 2 tablets every 6 hours
  • Do not take more than 8 tablets in 24 hours
  • Children under 12 years: ask a doctor

Other Information
  • Store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients
  • Corn starch
  • Crospovidone
  • Hypromellose
  • Microcrystalline cellulose
  • Povidone
  • Propylene glycol
  • Sodium Lauryl sulfate
  • Sodium starch glycolate
  • Stearic acid
  • Titanium dioxide

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM- 5PM EST or www.healthlifeofusa.com

Extra Strength Headache Relief
Acetaminophen 250mg / Pain Reliever
Aspirin 250mg (Nsaid) / Pain Reliever
Caffeine 65mg / Pain Reliever Aid 
24 Caplets

Compare to Excedrin® Extra Strength active ingredients 

Distributed by:
Healthlife of USA LLC
Rahway
NJ 07065
www.healthlifeofusa.com

EXTRA STRENGTH HEADACHE RELIEF 
extra strength headache relief tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-105
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
CAFFEINE (CAFFEINE) CAFFEINE65 
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
HYPROMELLOSES 
MICROCRYSTALLINE CELLULOSE 
POVIDONE 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapecapsuleSize18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69517-105-241 BOTTLE in 1 CARTON
124 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/31/2017
Labeler - Healthlife of USA (079656178)
Establishment
NameAddressID/FEIOperations
Healthlife of USA079656178repack(69517-105)
Establishment
NameAddressID/FEIOperations
Elysium Pharmaceuticals limited915664486manufacture(69517-105), pack(69517-105)

 
Healthlife of USA

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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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