Indications and uses
For the temporary relief of minor aches and pains associated with • headache • muscular aches • minor arthritis pain • back pain • common cold • toothache • menstrual cramps Temporarily reduces fever.
Handy Solutions Headache Pain Relief
- Manufacturer
- Navajo Manufacturing Company Inc.
- Effective date
- 2019-11-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:55:11
Label at a glance#
ProductHandy Solutions Headache Pain Relief
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure8 sections
Dosage and administration
• do not use more than directed Adults and children (12 years and older): Take 2 tablets with water every 6 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each tablet)
Acetaminophen 250 mg
Aspirin (NSAID*) 250 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purposes
Pain Reliever/Fever Reducer
Pain Reliever Aid
Uses
For the temporary relief of minor aches and pains associated with
• headache • muscular aches • minor arthritis pain • back pain • common cold • toothache • menstrual cramps
Temporarily reduces fever.
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 of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin (NSAID) may cause a severe allergic reaction which may include:
• hives • skin reddening • facial swelling • rash • asthma (wheezing) • shock • blisters
If an allergic 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:
• 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
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• for pain for more than 10 days unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
• if you ever have had an allergic reaction to any other pain relievers/ fever reducers
• right before or after heart surgery
• if you are taking prescription drugs for gout, diabetes, or arthritis
Ask a doctor before use if
• stomach bleeding warning applies to you
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have a history of stomach problems such as heartburn
• you have asthma
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin • under a doctor’s care for any serious condition • taking any other drug
When using this product
• take with food or milk if stomach upset occurs
Stop use and ask a doctor if
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
• symptoms do not improve • pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• ringing in the ears or loss of hearing occurs
• redness or swelling is present in the painful area • any new symptoms appear
If pregnant or breast-feeding,
ask a health care 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. 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 use more than directed
Adults and children (12 years and older): Take 2 tablets with water every 6 hours as needed. Do not take more than 8 tablets in 24 hours.
Children under 12 years: Do not give to children under 12 years of age.
Other Information
• read all product information before using
• store at room temperature 59°-86°F (15°-30°C)
• avoid excessive heat and humidity • tamper evident sealed packets
• do not use any opened or torn packets
Inactive Ingredients
hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide
Questions or comments?
call 1-800-525-5097
Package Labeling:
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67751-175-01 | 2023-03-17 | C162847 | 48780-1 | ba0f9c33-17aa-a910-e053-dadaa90a0b85 | Handy Solutions® Headache Pain Relief |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 47682-228-13 | EA - Each | 47682-228 | 20ec9c8d-ab39-43d1-baca-c844b0d07268 | 1 | 2012-07-24 |
| 47682-228-33 | EA - Each | 47682-228 | d17dd275-6ffb-4f53-a585-1502520cffe3 | 1 | 2012-07-24 |
| 47682-228-47 | EA - Each | 47682-228 | eba5432e-920e-4623-b99f-92fa7bcbfcbe | 1 | 2012-07-24 |
| 47682-228-64 | EA - Each | 47682-228 | 2f22a705-ce2f-4523-a25c-8ffeca7ef8d0 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- Handy Solutions Headache Pain Relief
- ACETAMINOPHEN, ASPIRIN, CAFFEINE
- HYPROMELLOSES
- MALTODEXTRIN
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- STEARIC ACID
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- ASPIRIN
- CAFFEINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67751-175 | 67751-175-01 |
| 47682-228 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | 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 |
|---|---|---|---|---|---|---|
| f70af04f-9e1a-61e1-e053-6294a90ab4eb | bb5456f0-c202-4717-9668-9c9dce2daefd | 2023-03-16 | Warnings | bb5456f0-c202-4717-9668-9c9dce2daefd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.