NDC 50405-008 Sohmed Pain Reliever

NDC Product Code 50405-008

NDC 50405-008-24

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 24 TABLET in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Sohmed Pain Reliever with NDC 50405-008 is a product labeled by Sohm Inc.. The generic name of Sohmed Pain Reliever is . The product's dosage form is and is administered via form.

Labeler Name: Sohm Inc.

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POVIDONES (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sohm Inc.
Labeler Code: 50405
Start Marketing Date: 08-25-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2018 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Aspirin

Aspirin is pronounced as (as' pir in)
Why is aspirin medication prescribed?
Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused ...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]
Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)
Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]

* Please review the disclaimer below.

Sohmed Pain Reliever Product Label Images

Sohmed Pain Reliever Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Distributed by : Sohm, Inc.6920 Knott Ave., Suit A-C, Buena Park, CA 90621

Otc - Purpose

Active ingredients (in each caplet)PurposesAcetaminophen 250mgpain relieverAspirin 250mg (NSAID)This Product is not manufactured or distributed by Novartis Consumer Healthcare, Inc. Owner of registered trademark Excedrin®.Pain relieverCaffeine 65mgpain reliever aid

Uses

  • Temporarily relieves minor aches and pains due to:Headachea coldarthritismuscular achessinusitistoothachepremenstrual & menstrual cramps.

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.Although rare, possible reactions to consumption of acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of the skin. If you are taking this product and develop a rash or other skin reaction, stop taking this product immediately and seek medical attention.

Allergy Alert

  • Aspirin may cause a severe allergic reaction which may include :hivesfacial swellingasthma (wheezing)shock

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if you take.adult takes more than 8 caplets in 24 hours, which is the maximum daily amount.Child takes more than 5 caplets in 24 hours.with other drugs containing acetaminophen.3 or more alcoholic drinks every day while using this product.

Stomach Bleeding Warning

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

Caffeine Warning

The recommended dose of this product contains about as much as 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 heart beat.

Do Not Use

  • If you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducerwith any 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 a liver diseasestomach bleeding warning applies to youyou have not been drinking fluidsyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking a diureticyou have asthmayou have lost a lot of fluids due to vomiting or diarrhea

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you are takingany other drug containing an NSAID (prescription or nonprescription)a blood thinning (anticoagulant) or steroid druga prescription drug for diabetes, gout or arthritisany other drug, or are under a doctor's care for any serious condition

Stop Use And Ask A Doctor If

  • An allergic reaction occurs. seek medical help right awayyou experience any of the following signs of stomach bleedingfeel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betterringing in the ears or loss of hearing occurspainful area is red or swollenpain gets worse or lasts for more than 10 daysfever gets worse or lasts for more than 3 days

Otc - Pregnancy Or Breast Feeding

  • Any new symptoms appear if pregnant or breast-feeding, ask 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

Keep out of reach of children.

Overdose Warning

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 directeddrink a full glass of water with each doseadults and children 12 years and over : take 2 caplets every 6 hours; not more than 8 caplets in 24 hourschildren under 12 years: asks a doctor.

Other Information

  • Store at controlled room temperature 20°-25°C(68°-77°F)See end flap or expiration date and lot number.

Inactive Ingredients

Benzoic acid, carnauba wax, FD&C blue#1, hydroxypropylcellulose, Hypromellose,light mineral oil, microcrystalline cellulose, polysorbate 20, Povidone, propylene glycol,simethicone emulsion, Sorbitan monolaurate, stearic acid, titanium dioxide.

Question And Comment?

1(856) 2863646

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