EXTRA STRENGTH HEADACHE RELIEF- extra strength headache relief tablet, coated 
Healthlife of USA

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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

image description

EXTRA STRENGTH HEADACHE RELIEF 
extra strength headache relief tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69517-105-241 in 1 CARTON05/31/201712/31/2021
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01305/31/201712/31/2021
Labeler - Healthlife of USA (079656178)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceuticals limited915664486manufacture(69517-105) , pack(69517-105)

Revised: 6/2024
 
Healthlife of USA