Timely Tension Headache Relief
05364eb4-07a1-a4d9-e063-6294a90a47e5
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 65 mg
Medication Information
Warnings and Precautions
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.
Indications and Usage
Uses
Temporarily relieves minor aches and pains due to:
- headache
- muscular aches
Dosage and Administration
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
Description
Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 65 mg
Section 44425-7
Other information
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Section 50565-1
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 50566-9
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.
Section 50568-5
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
Section 50569-3
Ask a doctor before use if
- you have liver disease
Section 50570-1
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
Section 51727-6
Inactive ingredients carnauba wax, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
Section 51945-4
Section 53413-1
Questions or comments? Call 1-877-290-4008
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purposes
Pain reliever
Pain reliever aid
Section 55106-9
Active ingredients (in each caplet)
Acetaminophen 500 mg
Caffeine 65 mg
Structured Label Content
Indications and Usage (34067-9)
Uses
Temporarily relieves minor aches and pains due to:
- headache
- muscular aches
Dosage and Administration (34068-7)
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
Warnings and Precautions (34071-1)
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.
Section 44425-7 (44425-7)
Other information
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Section 50565-1 (50565-1)
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 50566-9 (50566-9)
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.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
Section 50569-3 (50569-3)
Ask a doctor before use if
- you have liver disease
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
Inactive ingredients carnauba wax, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions or comments? Call 1-877-290-4008
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Purposes
Pain reliever
Pain reliever aid
Section 55106-9 (55106-9)
Active ingredients (in each caplet)
Acetaminophen 500 mg
Caffeine 65 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:30.393832 · Updated: 2026-03-14T23:13:07.898715