FDA.reportPublic FDA data

Headache Relief

Manufacturer
Family Dollar (FAMILY WELLNESS)
Effective date
2024-03-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:07:17

Label at a glance#

ProductHeadache Relief Extra Strength
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches 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 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

Storage and handling

store between 20º-25ºC (68º-77ºF)

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever

Pain reliever

Pain reliever aid

Uses

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
  • shock
  • asthma (wheezing)

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 heartbeat.

Do not use

OTC - DO NOT USE SECTION

  • 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 a doctor before use if

OTC - ASK DOCTOR SECTION

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

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 doctor if

OTC - STOP USE SECTION

  • an allergic reaction occurs. Seek medical help right away.
    • any new symptoms appear
  • 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
  • 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

these could be signs of a serious condition.

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 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 caplets every 6 hours; do not take more than 8 caplets in 24 hours
  • children under 12 years: do not use unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20º-25ºC (68º-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax**, colloidal silicon dioxide, corn starch, hypromellose, microcrystalline cellulose, mineral oil**, polyethylene glycol**, povidone, sodium starch glycolate**, stearic acid, talc**, titanium dioxide

**contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENTS OF EXCEDRIN®  EXTRA STRENGTH†

EXTRA STRENGTH

HEADACHE RELIEF

Acetaminophen 250 mg - Pain reliever

Aspirin (NSAID) 250mg - Pain reliever

Caffeine 65 mg - Pain reliever aid

CAPLETS

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY WELLNESS Extra Strength Headache Relief
FAMILY WELLNESS Extra Strength Headache Relief

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-625-102023-01-23C16284748780-1d6a99b39-ec31-a426-e053-dadaa90af4c2Drug Facts
55319-625-102022-01-28C16284748780-1d6a99b39-ec31-a426-e053-dadaa90af4c2Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-625HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]6Legacy NDC20240328_533eba29-c03c-498b-906f-37f638049029.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-62555319-625-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ASPIRINR16CO5Y76EACTIB
CAFFEINE3G6A5W338EACTIB
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
0924bbcb-e6c1-4d20-acc5-99413749c4da533eba29-c03c-498b-906f-37f6380490292024-03-27WarningsExact identifier
spl id: 0924bbcb-e6c1-4d20-acc5-99413749c4da
spl set id: 533eba29-c03c-498b-906f-37f638049029

Reported adverse events (FAERS/openFDA)#

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