FDA.reportPublic FDA data

Tension Headache Relief

Manufacturer
TIME CAP LABS INC
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:39:40

Label at a glance#

ProductTension Headache Relief
Active ingredientACETAMINOPHEN, CAFFEINE
Label structure9 sections

Storage and handling

Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 65 mg

OTC - PURPOSE SECTION

Purposes

Pain reliever

Pain reliever aid

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

373R-200ct label373R-200ct label

373R-100s-label373R-100s-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN3
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD3
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49483-373-012025-02-10C16284748780-12cef2736-7d5b-d83d-e063-dadaa90ab31f373R Timely 49483-373 Tension Headache Relief
49483-373-012025-02-10C16284748780-12cef2736-7d5b-d83d-e063-dadaa90ab31fTimely Tension Headache Relief
49483-373-202025-02-10C16284748780-12cef2736-7d5b-d83d-e063-dadaa90ab31f373R Timely 49483-373 Tension Headache Relief
49483-373-202025-02-10C16284748780-12cef2736-7d5b-d83d-e063-dadaa90ab31fTimely Tension Headache Relief
49483-373-012025-01-30C16284748780-12cef2736-7d5b-d83d-e063-dadaa90ab31f373R Timely 49483-373 Tension Headache Relief
49483-373-012025-01-30C16284748780-12cef2736-7d5b-d83d-e063-dadaa90ab31fTimely Tension Headache Relief
49483-373-202025-01-30C16284748780-12cef2736-7d5b-d83d-e063-dadaa90ab31f373R Timely 49483-373 Tension Headache Relief
49483-373-202025-01-30C16284748780-12cef2736-7d5b-d83d-e063-dadaa90ab31fTimely Tension Headache Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-373-01Tension Headache Relief100 in 1 BOTTLETABLET1003
49483-373-20Tension Headache Relief200 in 1 BOTTLETABLET2003

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49483-37349483-373-20, 49483-373-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
CAFFEINE3G6A5W338EACTIB
POVIDONEFZ989GH94EIACT
FD&C BLUE NO. 2 ALUMINUM LAKE4AQJ3LG584IACT
STARCH, CORNO8232NY3SJIACT
CARNAUBA WAXR12CBM0EIZIACT
TALC7SEV7J4R1UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STEARIC ACID4ELV7Z65APIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-02-08full-release2026-06-01 00:54:45

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, CAFFEINETIME CAP LABS INC05364eb4-07a1-a4d9-e063-6294a90a47e52025-10-21WarningsExact identifier
ndc (package): 49483-373-01
ndc (package): 49483-373-20
ndc (product): 49483-373
ndc11 (package): 49483037301
ndc11 (package): 49483037320
spl id: 41a88134-f6df-0dac-e063-6394a90a3e49
spl set id: 05364eb4-07a1-a4d9-e063-6294a90a47e5

Reported adverse events (FAERS/openFDA)#

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