Tension Headache Relief

SPL v1

SPL

SPL Set ID c3a57a57-0b56-80ca-e053-2a95a90a4eac

Route

ORAL

Published

Effective Date 2017-06-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Caffeine (65 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium D&c Red No. 27 Fd&c Blue No. 1 Fd&c Yellow No. 6 Magnesium Stearate Microcrystalline Cellulose Starch, Pregelatinized Corn Stearic Acid Talc Titanium Dioxide Polyethylene Glycol, Unspecified Povidone

Identifiers & Packaging

Pill Appearance

Shape: capsule Color: red Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-03-01

Description

Tension Headache Relief

Purpose

Pain reliever, Pain reliever aid

Medication Information

Purpose

Pain reliever, Pain reliever aid

Description

Tension Headache Relief

Uses

Temporarily relief 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 6 tablets 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.

Directions

Do not exceed recommended dosage.
Adults and children 12 years and over: Take 2 tablets every 6 hours; do not take more than 6 tablets in 24 hours
Children under 12 years: Ask a doctor

Drug Facts

Tension Headache Relief

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

Other Information

Store at controlled room temperature 20°-25°C (68°-77°F)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP

Inactive Ingredients

Colloidal silicon doixide
Croscarmellose sodium
D&C red # 27
FD&C blue # 1
FD&C yellow # 6
Magnesium stearate
Microcrystalline cellulose
Polyethylene glycol
Pregelatinized starch
Polyvinyl pyrolidone
Stearic acid
Talc
Titanium dioxide

Questions Or Comments?

Call toll free 1-844-384-3723 Monday through Friday 9AM - 5PM EST or www.safrel.com

Ask A Doctor Before Use

if you have liver disease

Tension Headache Relief

Ask A Doctor Or Pharmacist

If you are taking the blood thinning drug warfarin.

Stop Use and Ask A Doctor If

Any new symptoms appear
Symptoms do not get better or worsen
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

If Pregnant Or Breast Feeding

Ask a health professional before use.

Keep Out of Reach of Children.

In case of overdosage, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Caplet)

Acetaminophen 500mg

Caffeine 65mg

Structured Label Content

Uses

Temporarily relief minor aches and pains due to:

Headache
Muscular aches

Purpose

Pain reliever, Pain reliever aid

Warnings

Liver warning: This product contains acetaminophen. severe liver damage may occur if you take:

more than 6 tablets 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

Directions

Do not exceed recommended dosage.
Adults and children 12 years and over: Take 2 tablets every 6 hours; do not take more than 6 tablets in 24 hours
Children under 12 years: Ask a doctor

Drug Facts

Tension Headache Relief

Do Not Use (Do not Use )

with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

Other Information

Store at controlled room temperature 20°-25°C (68°-77°F)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP

Inactive Ingredients

Colloidal silicon doixide
Croscarmellose sodium
D&C red # 27
FD&C blue # 1
FD&C yellow # 6
Magnesium stearate
Microcrystalline cellulose
Polyethylene glycol
Pregelatinized starch
Polyvinyl pyrolidone
Stearic acid
Talc
Titanium dioxide

Questions Or Comments? (Questions or comments?)

Call toll free 1-844-384-3723 Monday through Friday 9AM - 5PM EST or www.safrel.com

Ask A Doctor Before Use (Ask a doctor before use)

if you have liver disease

Tension Headache Relief

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

If you are taking the blood thinning drug warfarin.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Any new symptoms appear
Symptoms do not get better or worsen
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

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredients (in Each Caplet) (Active Ingredients (in each caplet))

Acetaminophen 500mg

Caffeine 65mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relief minor aches and pains due to: Headache Muscular aches", "Purpose": "Pain reliever, Pain reliever aid", "Warnings": "Liver warning: This product contains acetaminophen. severe liver damage may occur if you take: more than 6 tablets 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.", "Directions": "Do not exceed recommended dosage. Adults and children 12 years and over: Take 2 tablets every 6 hours; do not take more than 6 tablets in 24 hours Children under 12 years: Ask a doctor", "Drug Facts": "Tension Headache Relief", "Do not Use ": "with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.", "Other Information": "Store at controlled room temperature 20°-25°C (68°-77°F) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP ", "Inactive Ingredients": "Colloidal silicon doixide Croscarmellose sodium D&C red # 27 FD&C blue # 1 FD&C yellow # 6 Magnesium stearate Microcrystalline cellulose Polyethylene glycol Pregelatinized starch Polyvinyl pyrolidone Stearic acid Talc Titanium dioxide", "Questions or comments?": "Call toll free 1-844-384-3723 Monday through Friday 9AM - 5PM EST or www.safrel.com", "Ask a doctor before use": "if you have liver disease", "Ask a doctor or pharmacist": "If you are taking the blood thinning drug warfarin.", "Stop use and ask a doctor if": "Any new symptoms appear Symptoms do not get better or worsen 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", "If pregnant or breast-feeding": "Ask a health professional before use.", "Keep out of reach of children.": "In case of overdosage, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Active Ingredients (in each caplet)": "Acetaminophen 500mg Caffeine 65mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:34.348466 · Updated: 2026-03-14T22:59:37.411151