Active Ingredients (In Each Caplet)
Acetaminophen 500mg
Caffeine 65 mg
Tension Headache Relief Tablet
FDA Label NDC 84324-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Tension Headache Relief (NDC 84324-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purpose, uses:, warnings:, stop use and ask doctor if, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acetaminophen 500mg................................Pain reliever
Caffeine 65mg............................................Pain reliever aid
Uses:
temporarily relieves minor aches and pains due to:
•headache
•muscular aches
Warnings:
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.
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
•no more than 6 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
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
•with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Stop Use And Ask 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.
Directions
- Do not use more than directed
- adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
- chlidren 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 # 27, F D & C yellow # 6, F D & C Blue # 2, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Pyrrolidone, Pregelatinized Starch, Polyvinyl Alcohol, Stearic Acid Powder, Titanium Dioxide, Talc.
Questions Or Comments?
Call 1 (718) 337-8733 or visit [email protected]
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