TENSION HEADACHE RELIEF

Set ID
1db2f78b-2279-49e5-b11c-640aec6c6e0c
Manufacturer
SPIRIT PHARMACEUTICALS LLC
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:41:49

Key Label Information

Active Ingredients And Purpose

OTC - PURPOSE SECTION

Active ingredients (in each caplet) Purposes Acetaminophen 500 mg Pain reliever Caffeine 65 mg Pain reliever aid

Uses

Uses

temporarily relieves minor aches and pains due to: headache muscular aches

Warnings

WARNINGS SECTION

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 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. 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.

Directions And Dosage

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 Label Information

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?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Tension Headache Relief Acetaminophen 500 mg, Caffeine 65 mg Pain Reliever 15 Caplets

Products

NDC Codes

Ingredients

NameUNIIKind
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE K30U725QWY32XIACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 272LRS185U6KIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
CAFFEINE3G6A5W338EACTIB

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet) Purposes Acetaminophen 500 mg Pain reliever Caffeine 65 mg Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to: headache muscular aches

WARNINGS SECTION

WARNINGS SECTION

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 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. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tension Headache Relief Acetaminophen 500 mg, Caffeine 65 mg Pain Reliever 15 Caplets

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc28f036d8-99f3-2911-e063-6394a90a1e48.xml2024-12-12
otc0c01ef09-a31b-5d64-e063-6394a90a0edc.xml2023-12-09
otcee8efe74-df7b-41b8-e053-2a95a90ac2bc.xml2022-11-30
otccfd2e7c2-3f14-2b6e-e053-2995a90af6cb.xml2021-11-03
otcc10c72a5-2996-18ab-e053-2a95a90a813d.xml2021-04-29
otcTH RELIEF.jpg2021-04-29