Headache Relief

Manufacturer
Grocery Outlet
Effective date
2026-03-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:50:32

Label at a glance#

ProductHeadache Relief Extra Strength
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure9 sections

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; not more than 8 tablets in 24 hours children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg
Aspirin 250 mg (NSAID*) 
Caffeine 65 mg

* nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever
Pain reliever
Pain reliever aid

Use(s)

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to

  • headache
  • a cold
  • arthritis
  • muscular aches
  • 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 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

  • adult takes more than 8 tablets in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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

OTC - DO NOT USE SECTION

  • if you have ever had an allergic reaction to
    acetaminophen, aspirin or 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 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 are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 or lasts for more than 10 days
  • ever gets worse or lasts for more than 3 days
  • any new symptoms occur
    These could be signs of a serious condition

If pregnant or breastfeeding,

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 specifically
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 the 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; not more than 8 tablets in 24 hours

children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, crospovidone, hypromellose, microcrystalline
cellulose, polyethylene glycol, povidone, pregelatinized
starch, silicon dioxide, stearic acid, titanium dioxide

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-877-290-4008

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonLabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN2
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD2
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810159835541GTIN-13: 0810159835541
EAN-13: 0810159835541
GTIN-12: 810159835541
UPC-A: 810159835541
GTIN storage (14 digits): 00810159835541
headache-relief-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85828-285-93Headache ReliefExtra Strength24 in 1 BOTTLETABLET, FILM COATED242
85828-285-93Headache ReliefExtra Strength1 in 1 CARTONTABLET, FILM COATED12

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85828-28585828-285-93

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

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
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEGrocery Outlet7398a372-7679-423b-a3ca-8da905a979dd2026-03-17WarningsExact identifier
ndc (package): 85828-285-93
ndc (product): 85828-285
ndc11 (package): 85828028593
spl id: 4c1e439b-8e75-4950-8e73-8fe0e51a50ff
spl set id: 7398a372-7679-423b-a3ca-8da905a979dd

Reported adverse events (FAERS/openFDA)#

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