Indications and uses
Temporarily relieves minor aches and pains due to: • headache • muscular aches
Tension Headache Relief
- Manufacturer
- Spirit Pharmaceuticals LLC
- Effective date
- 2024-12-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:49:36
Label at a glance#
ProductTension Headache Relief
Active ingredientACETAMINOPHEN, CAFFEINE
Label structure16 sections
Dosage and administration
• do not use more than directed • adults and children 12 years and over; take 2 tablets every 6 hours; not more than 6 tablets in 24 hours • children under 12 years: ask a doctor
Storage and handling
• Store at 20°–25°C (68°–77°F) • close cap tightly after use • read all product information before using
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient (in each tablet)
Acetaminophen 500 mg
Caffeine 65 mg
Purpose
Pain reliever
Pain reliever aid
Uses
Temporarily relieves minor aches and pains due to: • headache • muscular aches
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 6 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
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.
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 are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
liver disease
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
Stop use and ask a doctor if
• any new symptoms occur • 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. These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
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 (1-800-222-1222).
Directions
• do not use more than directed • adults and children 12 years and over; take 2 tablets every 6 hours; not more than 6 tablets in 24 hours • children under 12 years: ask a doctor
Other Information
• Store at 20°–25°C (68°–77°F) • close cap tightly after use • read all product information before using
Inactive ingredients
Colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 27, FD&C Blue No. 2, FD&C Yellow No. 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, stearic acid, talc, titanium dioxide
Questions or comments?
1-888-333-9792
Distributed by:
Cabinet Health P.B.C.
Pouch
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-4184-3 | Tension Headache Relief | 30 in 1 POUCH | TABLET, FILM COATED | 30 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-4184 | TENSION HEADACHE RELIEF (ACETAMINOPHEN AND CAFFEINE) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC] | 5 | Legacy NDC, 1 package rows | 20250101_1f6d9723-9e11-4973-af3a-66a6a7ad5cc3.zip |
Products#
Every source-derived product name is available through these pages.
- Tension Headache Relief
- Acetaminophen and Caffeine
- CROSCARMELLOSE SODIUM
- SILICON DIOXIDE
- D&C RED NO. 27
- FD&C BLUE NO. 2
- FD&C YELLOW NO. 6
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- POVIDONE
- STARCH, CORN
- WATER
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- CAFFEINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68210-4184 | 68210-4184-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 2a82ccc1-992f-6bae-e063-6294a90ac2de | 1f6d9723-9e11-4973-af3a-66a6a7ad5cc3 | 2024-12-30 | Warnings | 2a82ccc1-992f-6bae-e063-6294a90ac2de 1f6d9723-9e11-4973-af3a-66a6a7ad5cc3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.