Active Ingredient
Acetaminophen 500mg
Caffeine 65 mg
Tension Headache Relief Tablet
FDA Label NDC 72090-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Tension Headache Relief (NDC 72090-004). 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 ingredient, purpose, uses:, warnings:, ask doctor:, ask doctor/pharmacist:, stop use and ask a doctor if, pregnancy, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
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
•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 are allergic 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.
Ask Doctor:
Ask a doctor before use if
•you have liver disease
Ask Doctor/Pharmacist:
Ask a doctor or pharmacist before use if you are
•taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
•an allergic reaction occurs. Seek medical help right away.
•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
•ringing in the ears or loss of hearing occurs
•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
•any new symptoms appear
These could be signs of a serious condition.
Pregnancy
If pregnant or breast-feeding,
ask a health professional before use.
Keep Out Of Reach Of Children
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.
Directions
•do not use more than directed
•drink a full glass of water with each dose
•adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets 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#27, FD&C Blue# 2, FD&C Yellow#6,Magnesium Stearate,microcrystalline cellulose, polyethylene glycol, povidone,pregelatinized starch, stearic acid , talc, Titanium Dioxide.
Questions Or Comments?
Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com
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