Indications and uses
For the temporary relief of minor aches and pains due to: common cold headache toothache muscular aches backaches premenstrual and menstrual cramps minor pain from arthritis
NOTTS - Tension Headache
- Manufacturer
- VIVUNT PHARMA LLC
- Effective date
- 2023-11-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:02:43
Label at a glance#
ProductNOTTS - Tension Headache
Active ingredientACETAMINOPHEN, CAFFEINE
Label structure9 sections
Dosage and administration
Do not use more than directed Do not take more than 6 caplets in 24 hours, or as directed by a doctor adults and children 12 years and over take 2 caplets every 6 hours children under 12 years ask a doctor
Storage and handling
Store between 20-25 °C (68-77 °F) Tamper-evident: Do not use if carton is open or the foil inner seal is broken or missing.
Contacts and useful links#
Websitewww.vivunt.live
www.vivunt.live
www.vivunt.liveLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each caplet) | Purpose |
| Acetaminophen 500 mg | Pain Reliever |
| Caffeine 65 mg | Pain reliever Aid |
Uses
For the temporary relief of minor aches and pains due to:
- common cold
- headache
- toothache
- muscular aches
- backaches
- premenstrual and menstrual cramps
- minor pain from arthritis
Warnings
Liver Warning:
Liver warning: This product contains acetaminophen.
Severe damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day ehile using this product.
Allergy alert:
Acetaminophen may cause severe sking reactions. Symptoms may include:
- skin reddening
- rash
- blisters.
If a skin reactions occurs, stop use and seek medical attention immediately
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
- 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 are allergic to acetaminophen or any of the inactive ingredients.
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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition
If pregnant or breast-feeding,
ask a healt professional before use.
Keep out of the reach of children
Overdose warning:
Do not take more than recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. 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
- Do not take more than 6 caplets in 24 hours, or as directed by a doctor
| adults and children 12 years and over |
|
| children under 12 years |
|
Other information
- Store between 20-25 °C (68-77 °F)
- Tamper-evident: Do not use if carton is open or the foil inner seal is broken or missing.
Inactive ingredients
Croscarmellose Sodium, D&C Red No.27 Aluminium Lake, Magnesium Stearate, Microcrystalline Cellulose, Polacrilin Potassium, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch, Talc.
SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by GSK group of companies, owner of the registered trademark Excedrin® Tension Headache Caplets.
Distributed by: VIVUNT PHARMA LLC
8950 SW 74th Court, Suite 1901
Miami, FL 33156-3178
Made in India.
Package Principal Display Panel - TH 24 Caplets
NOTTS®
Tension Headache
500 mg 65 mg each caplet
- Headaches Relief
- Aspirin Free
Compare to Excedrin ® Tension Headache active ingredients*
NDC 82706-010-01
24 CAPLETS
Package Principal Display Panel - TH 100 Caplets
NOTTS®
Tension Headache
500 mg 65 mg each caplet
Headaches Relief
Aspirin Free
Compare to Excedrin® Tension Headache active ingredients*
NDC 82706-010-02
100 CAPLETS
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 |
|---|---|---|---|---|---|---|
| 82706-010-01 | NOTTS - Tension Headache | 24 in 1 BOTTLE, PLASTIC | TABLET | 24 | 4 | |
| 82706-010-01 | NOTTS - Tension Headache | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 82706-010-02 | NOTTS - Tension Headache | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 82706-010-02 | NOTTS - Tension Headache | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- NOTTS - Tension Headache
- Acetaminophen, Caffeine
- TALC
- D&C RED NO. 27 ALUMINUM LAKE
- SODIUM STARCH GLYCOLATE TYPE A
- STARCH, CORN
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- SODIUM LAURYL SULFATE
- ACETAMINOPHEN
- POVIDONE
- CAFFEINE
- CROSCARMELLOSE SODIUM
- POLACRILIN POTASSIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82706-010 | 82706-010-01, 82706-010-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TALC | 7SEV7J4R1U | IACT |
| D&C RED NO. 27 ALUMINUM LAKE | ZK64F7XSTX | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| POVIDONE | FZ989GH94E | IACT |
| CAFFEINE | 3G6A5W338E | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| POLACRILIN POTASSIUM | 0BZ5A00FQU | IACT |
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 |
|---|---|---|---|---|---|---|
| NOTTS - Tension Headache | ACETAMINOPHEN, CAFFEINE | VIVUNT PHARMA LLC | 08f2ae03-967b-ad7e-e063-6294a90a8484 | 2023-11-24 | Warnings | 82706-010-02 82706-010-01 82706-010 82706001002 82706001001 0aeeedc8-dcb9-087d-e063-6394a90ad1f5 08f2ae03-967b-ad7e-e063-6294a90a8484 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.