Headache Relief

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2026-08-09
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-08-12 01:01:27

Label at a glance#

ProductGenCare Headache Relief
Active ingredientCAFFEINE, ACETAMINOPHEN, ASPIRIN
Label structure14 sections

Indications and uses

temporarily relieves minor aches and pains due to: •headache •a cold •arthritis •muscular aches •toothache •premenstrual & 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 of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours ■ children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active Ingredients  (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Aspirin 250 mg
Caffeine 65 mg

Purpose

OTC - PURPOSE SECTION

Acetaminophen 250 mg............................................................Pain reliever
Aspirin 250 mg (NSAID*)..........................................................Pain reliever
Caffeine 65 mg ..................................................................Pain reliever aid
(*nonsteroidal anti-inflammatory drug)

Uses:

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:

•headache
•a cold
•arthritis
•muscular aches
•toothache
•premenstrual & 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 behavior 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: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.

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

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

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

•more than 8 caplets 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, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do not use

•if you have 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 whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask Doctor:

OTC - ASK DOCTOR SECTION

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 are taking a diuretic
•you have asthma

ASK DOCTOR/PHARMACIST:

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking

•a prescription drug for diabetes, gout, or arthritis
•any other drug, or are under a doctor’s care for any serious condition

OTC - STOP USE SECTION

Stop use and ask doctor if

■an allergic reaction occurs. Seek medical help right away.

■you experience any of the following signs of stomach bleeding:

■feel faint

■vomit blood

■have bloody or black stools

■have
stomach pain that does not get better

■ringing in the ears or loss of
hearing occurs

■painful area is red or swollen

■pain gets worse for more than 10 days

■fever gets worse or lasts more than 3 days

■any new symptoms occur. These could be signs of a serious condition.

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in
pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during
delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

■ do not use more than directed

■ drink a full glass of water with each dose

■ adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
■ children under 12 years: ask a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

■ Store between 20º-25ºC (68º-77ºF)
■ Close cap tightly after use

■ Read all product information before using.
■ Keep this box for important information.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearic Acid Powder, Talc.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call 1-732-698-5070 Monday through Friday 9 AM to 5 PM EST.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Headache Relief-ExcedrinHeadache Relief-Excedrin

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72090-007-022023-10-25C16284748780-1f386c64a-2e9d-0266-e053-dadaa90a7c1aHeadache Relief
72090-007-022023-10-25C16284748780-1f386c64a-2e9d-0266-e053-dadaa90a7c1aHeadache Relief
72090-007-022023-01-30C16284748780-1f386c64a-2e9d-0266-e053-dadaa90a7c1aHeadache Relief
72090-007-022023-01-30C16284748780-1f386c64a-2e9d-0266-e053-dadaa90a7c1aHeadache 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
72090-00772090-007-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-26full-release2026-06-01 01:28:45

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLCac8c4bdf-30c9-2b09-e053-2a95a90a9b672026-08-09WarningsExact identifier
ndc (package): 72090-007-02
ndc (product): 72090-007
ndc11 (package): 72090000702
spl id: ac3aad23-72ed-4908-929c-3abe3a3b175e
spl set id: ac8c4bdf-30c9-2b09-e053-2a95a90a9b67
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLC667f6f1b-5179-481c-a131-940c7937aada2025-12-26WarningsExact identifier
ndc (product): 72090-007

Reported adverse events (FAERS/openFDA)#

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