NDC 16103-353 Pharbetol Regular Strength

Product Information

What is NDC 16103-353?

The NDC code 16103-353 is assigned by the FDA to the product Pharbetol Regular Strength which is product labeled by Pharbest Pharmaceuticals, Inc.. The product's dosage form is and is administered via form. The product is distributed in 3 packages with assigned NDC codes 16103-353-07 1 bottle, plastic in 1 carton / 60 tablet in 1 bottle, plastic, 16103-353-08 1 bottle, plastic in 1 carton / 100 tablet in 1 bottle, plastic, 16103-353-11 1000 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code16103-353
Proprietary Name 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.		Pharbetol Regular Strength
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Pharbest Pharmaceuticals, Inc.
Labeler Code16103
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		01-09-2007
Listing Expiration Date 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.		12-31-2022
Exclude Flag 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". 		U
NDC Code Structure

What are the uses for Pharbetol Regular Strength?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)10 MM
Imprint(s)PH020
Score1

Product Packages

NDC Code 16103-353-07

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 60 TABLET in 1 BOTTLE, PLASTIC

Price per Unit: $0.01795 per EA

NDC Code 16103-353-08

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET in 1 BOTTLE, PLASTIC

Price per Unit: $0.01795 per EA

NDC Code 16103-353-11

Package Description: 1000 TABLET in 1 BOTTLE

Price per Unit: $0.01795 per EA

This product is EXCLUDED from the official NDC directory .

Product Details

Pharbetol Regular Strength Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Pharbetol Regular Strength Inactive Ingredients UNII Codes

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.

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Patient Education

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]

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Pharbetol Regular Strength Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient (Per Tablet)



Acetaminophen 325mg


Purpose



Pain reliever/Fever reducer


Uses



  • Temporarily relieves minor aches and pains due to
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • menstrual cramps
    • Temporarily reduces fever

Warnings



Liver warning:This product contains acetaminophen. Severe liver damage may occur if

  • Adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • Child takes more than 5 doses in 24 hours
  • Taken with other drugs containing acetaminophen
  • Adult has 3 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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor Before Use If You Have



liver disease.


Ask A Doctor Or Pharmacist Before Use If You Are



taking the blood thinning drug warfarin.


Stop Use And Ask A Doctor If



  • Pain gets worse or lasts more than 10 days in adults and children
  • Pain gets worse or lasts more than 5 days in children under 12 years
  • Fever gets worse or lasts more than 3 days
  • New symptoms occur
  • Redness or swelling is present

    • These could be sign of a serious condition.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of The Reach Of Children.




Overdose Warning:



Taking more than the recommended dose (overdose) may cause liver damage. In the case of accidental overdose, get medical help or contact a Poison Control Center right away.


Directions



  • do not take more than directed (see overdose warning).

    • Adults and children 12 years and over                     
    		Take 2 tablets every 4 to 6 while symptoms last.
    Do not take more than 12 tablets in 24 hours.
    Children 6 to under 12 years
    		Take 1 tablet every 4 to 6 while symptoms last.
    Do not take more than 5 tablets in 24 hours.
    Children under 6 years
    		Do not use adult regular strength products in childern under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other Information



  • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
  • store between 20-25°C (68-77°F)
  • use by expiration date on package

Inactive Ingredients:



Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.


Questions?



Adverse drug event call: (866) 562-2756


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