NDC 68737-224 Pm Get Relief

  1. Labeler Index
  2. Eagle Distributors,inc.
  3. NDC: 68737-224 Pm Get Relief

NDC Product Code 68737-224

NDC CODE: 68737-224

Proprietary Name: Pm Get Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This product is used as active ingredients (in each caplet)purposesacetaminophen 500 mgpain relieverdiphenhydramine hcl 25 mgnighttime sleep aid

Product Characteristics

Color(s):
BLUE (C48333)
Shape: OVAL (C48345)
Size(s):
17 MM
Imprint(s):
AZ;020
Score: 2

NDC Code Structure

NDC 68737-224-08

Package Description: 50 POUCH in 1 BOX > 2 TABLET in 1 POUCH

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

NDC Product Information

Pm Get Relief with NDC 68737-224 is product labeled by Eagle Distributors,inc.. The product's dosage form is and is administered via form.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TALC (UNII: 7SEV7J4R1U)

Product Labeler Information

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

Labeler Name: Eagle Distributors,inc.
Labeler Code: 68737
Start Marketing Date: 06-30-2012 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: 12-31-2017 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 - INACTIVATED, the listing data was inactivated by the FDA. 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* 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]
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.

Pm Get Relief Product Label Images

Pm Get Relief 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

Product manufactured for:Eagle Distributors,Inc.Los Angeles, CA 90011

Otc - Purpose

Active ingredients (in each caplet)PurposesAcetaminophen 500 mgPain relieverDiphenhydramine HCl 25 mgNighttime sleep aid

Uses

Temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if you takemore than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

Do Not Use

  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.with any product containing diphenhydramine, even one used on skinin children under 12 years of ageif you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have

  • Liver diseasea breathing problem such as emphysema or chronic bronchitistrouble urinating due to an enlarged prostate glandglaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarintaking sedatives or tranquilizers

When Using This Product

  • Drowsiness will occuravoid alcoholic drinksdo not drive a motor vehicle or operate machinery

Stop Use And Ask A Doctor If

  • Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.pain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurThese could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years of age and overTake 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.Children under 12 years of ageDo not use this adult strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems

Other Information

  • Store between20-25 C (68-77 F)do not use if pouch is torn or open

Inactive Ingredients

Croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide. May contain polyvinyl alcohol, silicon dioxide, sodium starch glycolate, talc.

* Please review the disclaimer below.