Extra Strength Headache Relief

Manufacturer
Healthlife of USA | Elysium Pharmaceuticals limited
Effective date
2021-10-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:33:36

Label at a glance#

ProductExtra Strength Headache Relief
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure15 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Pain reliever, Pain reliever aid

Active Ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250mg

Aspirin 250mg

Caffeine 65mg

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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 

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69517-105-242024-06-18C16284748780-1f386c64a-4971-0266-e053-dadaa90a7c1aExtra Strength Headache Relief
69517-105-242023-01-30C16284748780-1f386c64a-4971-0266-e053-dadaa90a7c1aExtra Strength Headache Relief

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-10569517-105-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
085b2e45-62bc-c1b9-e063-6394a90a4ce4a0cdc5d6-9995-4424-badd-db74e1e0bc3b2024-06-13WarningsExact identifier
spl set id: a0cdc5d6-9995-4424-badd-db74e1e0bc3b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.