Active Ingredient(S)
Acetaminophen 500 mg
Caffeine 65mg
Tension Headache Relief Capsule, Coated
FDA Label NDC 69168-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Tension Headache Relief (NDC 69168-001). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, stop use and ask a doctor if, 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
Use(S)
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 8 tablets in 24 hours, which is the maximum daily amount ■ take with other drugs containing acetaminophen ■ have 3 or more alcoholic drinks every day while using this product
Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
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.
Pregnancy/Breastfeeding
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.
Directions
Do not use more than directed
Adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
Children under 12 years: ask a doctor
Other Information
- Store at 20-25°C (68-77° F)
- Do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40
aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone,
pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
Questions
1-888-952-0050 (Monday through Friday 9AM - 5PM EST
Principal Display Panel
Tension Headache (Greenfield Tension Headache 1)
Tension Headache (Greenfield Tension Headache 2)
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