FDA.reportPublic FDA data

Tension Headache Relief

Manufacturer
Hi-Tech Nutraceuticals, LLC
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:52:22

Label at a glance#

ProductTension Headache Relief
Active ingredientACETAMINOPHEN, CAFFEINE
Label structure17 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ActivesActives

OTC - ASK DOCTOR SECTION

Ask a DoctorAsk a Doctor

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a D or PAsk a D or P

OTC - DO NOT USE SECTION

Do Not UseDo Not Use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

OTC - PREGNANCY OR BREAST FEEDING SECTION

if P or Bif P or B

OTC - PURPOSE SECTION

PurposesPurposes

OTC - QUESTIONS SECTION

QuestionsQuestions

OTC - STOP USE SECTION

Stop UseStop Use

OTC - WHEN USING SECTION

When UsingWhen Using

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

WARNINGS SECTION

WarningsWarnings

INACTIVE INGREDIENT SECTION

InactivesInactives

STORAGE AND HANDLING SECTION

Other InformationOther Information

OVERDOSAGE SECTION

OverdoseOverdose

INDICATIONS & USAGE SECTION

IndicationsIndications

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN4
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD4
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY4

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
69732-007-012024-01-30C16284748780-11030e365-51dd-111a-e063-dadaa90a10e2b119ba37-0ee3-851a-e053-2995a90a85b1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69732-007-01Tension Headache Relief100 in 1 BOTTLE, PLASTICTABLET1004

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69732-00769732-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
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
Tension Headache ReliefACETAMINOPHEN, CAFFEINEHi-Tech Nutraceuticals, LLCb119ba37-0ee3-851a-e053-2995a90a85b12026-03-31WarningsExact identifier
ndc (package): 69732-007-01
ndc (product): 69732-007
ndc11 (package): 69732000701
spl id: 4e542499-5955-50a8-e063-6294a90a46ed
spl set id: b119ba37-0ee3-851a-e053-2995a90a85b1

Reported adverse events (FAERS/openFDA)#

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