Sedal 3X

Manufacturer
OPMX LLC
Effective date
2026-09-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-30 01:01:37

Label at a glance#

ProductSEDAL3X
Active ingredientACETAMINOPHEN, CAFFEINE, ASPIRIN
Label structure9 sections

Indications and uses

Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual and menstrual cramps

Dosage and administration

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 tablets every 6 hours do not take more than 8 tablets in 24 hours children under 12 years: ask a doctor

Storage and handling

store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAPS IS BROKEN OR MISSING

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Active ingredients
(in each caplets)

Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

Uses
temporarily relieves minor aches and pains due to:
headache
a cold
arthritis
muscular aches
sinusitis
toothache
premenstrual and menstrual cramps

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction, which may include:
hives
shock
facial swelling
asthma (wheezing)

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take:
more than 8 tablets in 24 hours, wich is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Caffeine warning

SPL UNCLASSIFIED SECTION

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

if you ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis or kidney disease
you have asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

a prescription drug for diabetes, gout, or arthritis

taking any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience any of the following signs of stomach bleeding:
feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away if:
any new symptoms appear
ringing in the ears or loss of hearing occurs
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
painful area is red or swollen

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning

SPL UNCLASSIFIED SECTION

In case of overdose, 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 use more than directed
drink a full glass of water with each dose
adults and children 12 years and over:
take 2 tablets every 6 hours
do not take more than 8 tablets in 24 hours
children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAPS IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

SPL UNCLASSIFIED SECTION

Manufactured in:
GMP Registered Facility in the USA


Made for:

inov FARMACEUTIQUE

Exclusively distributed by:
OPMX
Chula Vista, CA 91910
PHONE: 619-600-5632

SPL UNCLASSIFIED SECTION

Sedal3x

Acetaminophen 250 mg

Aspirin 250 mg
Caffeine 65 mg

Pain Reliever

40 Caplets

PRINCIPAL DISPLAY PANEL - 40 CAPLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-055-40

Sedal3x

Acetaminophen 250 mg Pain reliever

Aspirin 250 mg Pain reliever
Caffeine 65 mg Pain reliever

40 Caplets

Sedal3X 40_capsSedal3X 40_caps

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130856828008878GTIN-13: 0856828008878
EAN-13: 0856828008878
GTIN-12: 856828008878
UPC-A: 856828008878
GTIN storage (14 digits): 00856828008878
Sedal3x 40_caps.jpg
QR code linkQR Codeopmx.us/Sedal3x 40_caps.jpg

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
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct 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
69729-055-402024-05-17C16284748780-11030e365-5e1e-111a-e063-dadaa90a10e2Sedal 3X
69729-055-402024-05-17C16284748780-11030e365-5e1e-111a-e063-dadaa90a10e2Sedal 3X
69729-055-402024-01-30C16284748780-11030e365-5e1e-111a-e063-dadaa90a10e2Sedal 3X
69729-055-402024-01-30C16284748780-11030e365-5e1e-111a-e063-dadaa90a10e2Sedal 3X

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-05569729-055-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-06-04full-release2026-06-01 00:13:23

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
SEDAL3XACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe9089f8b-3d23-5c81-e053-2995a90a42022024-06-04WarningsExact identifier
ndc (package): 69729-055-40
ndc (product): 69729-055
ndc11 (package): 69729005540
spl set id: e9089f8b-3d23-5c81-e053-2995a90a4202

Reported adverse events (FAERS/openFDA)#

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