FDA.reportPublic FDA data

Tension Headache Relief

Manufacturer
Safrel Pharmaceuticals, LLC.
Effective date
2021-05-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:39

Label at a glance#

ProductTension Headache Relief
Active ingredientACETAMINOPHEN, CAFFEINE
Label structure16 sections

Indications and uses

Temporarily relief minor aches and pains due to: Headache Muscular aches

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts

OTC - PURPOSE SECTION

Tension Headache Relief

Purpose

OTC - PURPOSE SECTION

Pain reliever, Pain reliever aid

Active Ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen   500mg

Caffeine   65mg

Uses

INDICATIONS & USAGE SECTION

Temporarily relief minor aches and pains due to:

  • Headache
  • Muscular aches

Warnings

WARNINGS SECTION

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.

Do not Use 

OTC - DO NOT USE SECTION

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

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • if you have liver disease

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

If you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other Information

INACTIVE INGREDIENT SECTION

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

Inactive Ingredients

OTC - QUESTIONS SECTION

  • 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?

OTC - QUESTIONS SECTION

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

Tension Headache Relief Acetaminophen 500mg Caffeine 65mg Compare to Excedrin® Tension Headache active ingredients Distributed by: Safrel Pharmaceuticals, LLC Bridgewater, NJ 08807 www.safrle.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THTH

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN1
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD1
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71309-105-022023-01-30C16284748780-1f386c64a-05a9-0266-e053-dadaa90a7c1aTension Headache Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71309-105-02Tension Headache Relief200 in 1 BOTTLETABLET, COATED2001
71309-105-24Tension Headache Relief24 in 1 BOTTLETABLET, COATED241
71309-105-24Tension Headache Relief1 in 1 CARTONTABLET, COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-105TENSION HEADACHE RELIEF (ACETAMINOPHEN 500MG) TABLET, COATED [SAFREL PHARMACEUTICALS, LLC.]1Legacy NDC, 3 package rows20210601_c3a57a57-0b56-80ca-e053-2a95a90a4eac.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71309-10571309-105-24, 71309-105-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 272LRS185U6KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
ACETAMINOPHEN362O9ITL9DACTIB
CAFFEINE3G6A5W338EACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c3a57a57-0b57-80ca-e053-2a95a90a4eacc3a57a57-0b56-80ca-e053-2a95a90a4eac2021-05-31WarningsExact identifier
spl id: c3a57a57-0b57-80ca-e053-2a95a90a4eac
spl set id: c3a57a57-0b56-80ca-e053-2a95a90a4eac

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.