FDA Label for Notts - Tension Headache
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- USES
- LIVER WARNING:
- ALLERGY ALERT:
- CAFFEINE WARNING:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- OVERDOSE WARNING:
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Notts - Tension Headache Product Label
The following document was submitted to the FDA by the labeler of this product Vivunt Pharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Otc - Purpose
Active ingredient (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
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.
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
- take 2 caplets every 6 hours
- ask 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.
Other
*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.
www.vivunt.live
Package Label.Principal Display Panel
NOTTS TM
Tension Headache
Acetaminophen, Caffeine
500 mg / 65 mg each caplet
Headaches Relief
Aspirin Free
Compare to Excedrin® Tension Headache active ingredients*
NDC 82706-010-01
24 CAPLETS
NOTTS TM
Tension Headache
500 mg 65 mg each caplet
- Headaches Relief
- Aspirin Free
Compare to Excedrin ® Tension Headache active ingredients*
NDC 82706-010-01
100 CAPLETS
* Please review the disclaimer below.