Seedalmerk by OPMX LLC Seedalmerk (OPMX)

Seedalmerk by

Drug Labeling and Warnings

Seedalmerk by is a Otc medication manufactured, distributed, or labeled by OPMX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SEEDALMERK- acetaminophen, aspirin, caffeine tablet 
OPMX LLC

----------

Seedalmerk (OPMX)

Drug Facts

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

Purpose
Pain reliever
Pain reliever
Pain reliever aid

Uses

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

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.

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.

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

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

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

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.

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.

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

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

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

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

label

SEEDALMERK 
acetaminophen, aspirin, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69729-203
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
TALC (UNII: 7SEV7J4R1U)  
POVIDONE K30 (UNII: U725QWY32X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Product Characteristics
Colorwhite (White to off white) Scorescore with uneven pieces
ShapeCAPSULESize18mm
FlavorImprint Code A2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69729-203-37100 in 1 CARTON10/05/202101/16/2023
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01310/05/202101/16/2023
Labeler - OPMX LLC (029918743)

Revised: 4/2024

Trademark Results [Seedalmerk]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SEEDALMERK
SEEDALMERK
88582951 not registered Live/Pending
Medimex, Inc
2019-08-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.