Indications and uses
temporarily relieves minor aches and pains due to: headache a cold arthritis toothache muscular aches premenstrual and menstrual cramps
CVP 44-159B
- Manufacturer
- Salado Sales, Inc. | LNK International, Inc.
- Effective date
- 2026-07-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 18
- Source
- daily-update
- Hydrated at
- 2026-07-21 05:10:15
Label at a glance#
ProductHeadache Relief Extra Strength
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure9 sections
Dosage and administration
do not take 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
Storage and handling
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each tablet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Pain reliever
Pain reliever aid
Uses
- temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- toothache
- muscular aches
- 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 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: Aspirin may cause a severe allergic reaction, which may include:
- hives
- facial swelling
- shock
- asthma (wheezing)
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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- 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
- take more or for a longer time than directed
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- 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
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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- you have asthma
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- stomach bleeding warning applies to you
- you have liver disease
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
- 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 a loss of hearing occurs
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
These could be signs of a serious condition.
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.
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take 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)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Questions or comments?
1-800-426-9391
Principal Display Panel
CVP®
HEALTH
COMPARE TO
EXCEDRIN® EXTRA STRENGTH
ACTIVE INGREDIENTS†
EXTRA STRENGTH
HEADACHE
RELIEF
ACETAMINOPHEN
ASPIRIN (NSAID), CAFFEINE
PAIN RELIEVER, PAIN RELIEVER AID
ACTUAL
SIZE
24
COATED TABLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by GSK
Consumer Healthcare SARL, owner of the registered trademark
Excedrin® Extra Strength. 50844 REV1121N15908
Distributed by Consumer Value Products, Inc.
P.O. Box 6115, Temple, Texas 76502
CVPproducts.com
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0761706161487 | GTIN-13: 0761706161487 EAN-13: 0761706161487 GTIN-12: 761706161487 UPC-A: 761706161487 GTIN storage (14 digits): 00761706161487 | cvp-44-159b-1.jpg |
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 2 | |
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 2 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 2 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 2 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 |
Products#
Every source-derived product name is available through these pages.
- Headache Relief Extra Strength
- Acetaminophen, Aspirin and caffeine
- ACETAMINOPHEN
- ASPIRIN
- CAFFEINE
- STARCH, CORN
- CROSPOVIDONE, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- SODIUM LAURYL SULFATE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57243-159 | 57243-159-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 17 | 2026-05-06 | full-release | 2026-06-01 01:56:23 |
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FILM COATED / ORAL | 240 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FILM COATED / ORAL | 240 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg |
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 |
|---|---|---|---|---|---|---|
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Salado Sales, Inc. | ca21d576-be3c-495d-9dbd-ed514bf65da7 | 2026-07-01 | Warnings | 57243-159-08 57243-159 57243015908 dcd94530-ff87-4cc8-ab8d-a04c7aece039 ca21d576-be3c-495d-9dbd-ed514bf65da7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.