Indications and uses
Temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual and menstrual cramps
Extra Strength Headache Relief
- Manufacturer
- Safrel Pharmaceuticals, LLC.
- Effective date
- 2021-09-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:42:32
Label at a glance#
ProductExtra Strength Headache Relief
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure15 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 Do not take more than 8 tablets in 24 hours Children under 12 years: ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
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 1-844-384-3723 Monday through Friday 9AM- 5PM EST or 
www.safrel.com
Extra Strength Headache Relief Acetaminophen 250mg / Pain Reliever Aspirin 250mg (Nsaid) / Pain Reliever Caffeine 65mg / Pain Reliever Aid Compare to Excedrin® Extra Strength active ingredients
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71309-118-03 | 2023-01-30 | C162847 | 48780-1 | f386c649-9c9b-0266-e053-dadaa90a7c1a | Extra Strength Headache Relief |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71309-118-03 | Extra Strength Headache Relief | 300 in 1 BOTTLE | TABLET, COATED | 300 | 2 | |
| 71309-118-24 | Extra Strength Headache Relief | 24 in 1 BOTTLE | TABLET, COATED | 24 | 2 | |
| 71309-118-24 | Extra Strength Headache Relief | 1 in 1 CARTON | TABLET, COATED | 1 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Extra Strength Headache Relief
- CROSPOVIDONE
- HYPROMELLOSES
- MICROCRYSTALLINE CELLULOSE
- POVIDONE
- PROPYLENE GLYCOL
- SODIUM LAURYL SULFATE
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- ASPIRIN
- CAFFEINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71309-118 | 71309-118-24, 71309-118-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSPOVIDONE | 2S7830E561 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| cd1ae029-289e-bdcc-e053-2995a90aeb95 | c3a63704-b289-5366-e053-2a95a90a1f82 | 2021-09-28 | Warnings | cd1ae029-289e-bdcc-e053-2995a90aeb95 c3a63704-b289-5366-e053-2a95a90a1f82 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.