FDA Label for Tension Headache Relief
View Indications, Usage & Precautions
Tension Headache Relief Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens. 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.
Other
Drug Facts
Otc - Purpose
| Active ingredients (in each caplet) | Purposes |
| Acetaminophen 500 mg | Pain reliever |
| Caffeine 65 mg | Pain reliever aid |
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
Warnings
Warnings
Liver Warning: This product contains acataminophen. Severe liver damage may occure if you take.
- more than 6 caplets in 24 hours, whihc is the maximum daily amount.
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
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, beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
Otc - Do Not Use
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.
Otc - Ask Doctor
Ask a doctor before use if you have
- liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
Otc - Stop Use
Stop use and ask a doctor if
- any new symptoms occur
- painful area is red or swollen
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts for more than 3 days
These could be signs of a serious condition
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding,
ask a health professional before use.
Otc - 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. 1-800-222-1222
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
- 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. Keep this box for important information.
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, polyvinyl alcohol, povidone, pregelatinized starch, purified water, stearic acid, talc, titanium dioxide
Questions Or Comments?
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Tension Headache Relief
• Acetaminophen & Caffeine
Pain Reliever/ Pain reliever aid
Actual Size
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