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#
Contacts and useful links#
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69729-203-37 | 2024-04-02 | C162847 | 48780-1 | 1030e365-0844-111a-e063-dadaa90a10e2 | Seedalmerk (OPMX) |
| 69729-203-37 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0844-111a-e063-dadaa90a10e2 | Seedalmerk (OPMX) |
Products#
Every source-derived product name is available through these pages.
- Seedalmerk
- Acetaminophen, Aspirin, Caffeine
- CROSPOVIDONE
- HYPROMELLOSE, UNSPECIFIED
- POLYETHYLENE GLYCOL 8000
- TALC
- POVIDONE K30
- TITANIUM DIOXIDE
- STEARIC ACID
- SILICON DIOXIDE
- LACTOSE, UNSPECIFIED FORM
- ISOPROPYL ALCOHOL
- ACETAMINOPHEN
- ASPIRIN
- CAFFEINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69729-203 | 69729-203-37 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSPOVIDONE | 2S7830E561 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | IACT |
| TALC | 7SEV7J4R1U | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 151fc9d7-376a-3844-e063-6294a90aa31c | d1689c3a-c70c-cf68-e053-2995a90a4c08 | 2024-04-02 | Warnings | d1689c3a-c70c-cf68-e053-2995a90a4c08 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
