Seedalmerk

Manufacturer
OPMX LLC
Effective date
2022-03-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:06:24

Label at a glance#

ProductSeedalmerk
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients(in each caplet)
Acetaminophen 250 mg
Aspirin (NSAID)* 250 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose
Pain reliever
Pain reliever
Pain reliever aid

INDICATIONS & USAGE SECTION

Uses

  • Temporarily relieves minor aches and pains due to:
  • headache
  • cold
  • arthritis
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps

WARNINGS SECTION

Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.


Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash
If skin reaction occurs, stop use and seek medical help right away.
Aspirin may cause severe allergic reaction, which may include:
• hives • shock • facial swelling • asthma (wheezing)


Liver warning: This product contains Acetaminophen. Severe liver damage may occur if you take:
• more than 8 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


Stomach bleeding warning:
This product contains 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: The recommended dose of this product contains about as much caffeine as a cup or coffee. Limit the use of caffeine-containig 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 ever had an allergic reaction to Acetaminophen, Aspirin or any other pain relievers/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.

OTC - ASK DOCTOR SECTION

Ask a doctor before useif you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drug or are under a doctor's care for any serious condition

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away.
  • ringing in the ears or loss of hearing occurs
  • 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
  • any new symptoms appear

These could be signs of a serious condition

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, 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.

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.
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
  • drink a full glass of water with each dose
  • adults and children (12 years and older): • take 2 caplets every 6 hours • do not take more than 8 caplets in 24 hours
  • children under 12 years: ask a doctor

SPL UNCLASSIFIED SECTION

Other information

  • store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
  • Avoid excessive heat and humidity.
  • TAMPER EVIDENT: DO NOT USE IF POUCH IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING
  • This package is child-resistant.
  • Keep the carton. It contains important information.
  • Read the directions and warnings before use.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Crospovidone, Silicon dioxide, Hypromellose, Isopropyl alcohol, Lactose, Polyethylene glycol 8000, Povidone K30, Talc, Stearic acid, Titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or www.opmx.us

SPL UNCLASSIFIED SECTION

Seedalmerk


Acetaminophen, Aspirin and Caffeine Tablets USP


Helps Relieve:

  • Pain and discomfort due to:
  • headache
  • cold
  • arthritis
  • muscular aches
  • sinusitis
  • toothache
  • premenstrual and menstrual cramps

200 Caplets

100 Pouches of 2 Caplets

Active ingredients (in each caplet) Purpose
Acetaminophen 250 mg Pain reliever
Aspirin 250 mg Pain reliever
Caffeine 65 mg Pain reliever aid

inov FARMACEUTIQUE
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
Phone: 619-600-5632

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-203-372024-04-02C16284748780-11030e365-0844-111a-e063-dadaa90a10e2Seedalmerk (OPMX)
69729-203-372024-01-30C16284748780-11030e365-0844-111a-e063-dadaa90a10e2Seedalmerk (OPMX)

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
69729-20369729-203-37

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

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
151fc9d7-376a-3844-e063-6294a90aa31cd1689c3a-c70c-cf68-e053-2995a90a4c082024-04-02WarningsExact identifier
spl set id: d1689c3a-c70c-cf68-e053-2995a90a4c08

Reported adverse events (FAERS/openFDA)#

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