Indications and uses
temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual & menstrual cramps
ValuMeds Extra Strength Headache Relief
- Manufacturer
- Cabinet Health P.B.C.
- Effective date
- 2025-01-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:56:30
Label at a glance#
ProductValuMeds Extra Strength Headache Relief
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure8 sections
Dosage and administration
do not use more than directed (see Overdose warning) drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each caplet)
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
- muscular aches
- sinusitis
- toothache
- premenstrual & 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: 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 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
- 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 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 heart disease, liver cirrhosis or kidney disease
- you are taking a diuretic
- you have high blood pressure
- you have asthma
Ask a doctor or pharmacist before use if you are
- any other drug containing an NSAID (prescription or non-prescription)
- a prescription drug for diabetes, gout or arthritis
- any other drug, or are under a doctor's care for any serious condition
- a blood thinning (anticoagulant) or steroid drug
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 or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- any new symptoms appear
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 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 right away 1-800-222-1222. 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 (see Overdose warning)
- drink a full glass of water with each dose
- adults and children 12 years 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
- each caplet contains: magnesium 0.58 mg
- store at controlled room temperature 20º - 25º C (68º - 77º F)
- read all product information before using.
Inactive ingredients
colloidal silicon dioxide, hypermellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, purified water, stearic acid, talc
Questions or comments?
contact 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST
Package Labeling:
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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82725-1023-1 | ValuMeds Extra Strength Headache Relief | 300 in 1 BOTTLE | TABLET | 300 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 82725-1023 | VALUMEDS EXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [CABINET HEALTH P.B.C.] | 1 | Current NDC, 1 package rows | 20250305_0f864e73-e4b8-4e23-8990-8439ac17bd58.zip |
Products#
Every source-derived product name is available through these pages.
- ValuMeds Extra Strength Headache Relief
- ACETAMINOPHEN, ASPIRIN, CAFFEINE
- SILICON DIOXIDE
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- WATER
- STEARIC ACID
- TALC
- ACETAMINOPHEN
- ASPIRIN
- ACETYLSALICYLIC ACID
- CAFFEINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82725-1023 | 82725-1023-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | 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 |
|---|---|---|---|---|---|---|
| ValuMeds Extra Strength Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Cabinet Health P.B.C. | 0f864e73-e4b8-4e23-8990-8439ac17bd58 | 2025-01-31 | Warnings | 82725-1023-1 82725-1023 82725102301 2d020795-9ffe-c174-e063-6394a90aae46 0f864e73-e4b8-4e23-8990-8439ac17bd58 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.