NDC 68071-4166 Acetaminophen 325 Mg

Acetaminophen

NDC Product Code 68071-4166

NDC 68071-4166-2

Package Description: 20 TABLET in 1 BOTTLE

NDC 68071-4166-3

Package Description: 30 TABLET in 1 BOTTLE

NDC 68071-4166-4

Package Description: 40 TABLET in 1 BOTTLE

NDC 68071-4166-5

Package Description: 25 TABLET in 1 BOTTLE

NDC 68071-4166-8

Package Description: 50 TABLET in 1 BOTTLE

NDC Product Information

Acetaminophen 325 Mg with NDC 68071-4166 is a a human over the counter drug product labeled by Nucare Pharmaceuticals,inc.. The generic name of Acetaminophen 325 Mg is acetaminophen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Nucare Pharmaceuticals,inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug 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.

Acetaminophen 325 Mg Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 325 mg/1

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.

  • STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • POVIDONE (UNII: FZ989GH94E)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Nucare Pharmaceuticals,inc.
Labeler Code: 68071
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-01-2015 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: 12-31-2020 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: N 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.

Acetaminophen 325 Mg 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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.Distributed by:



Reliable 1 Laboratories LLC, Valley Stream, NY 11580www.reliable1labs.com

Active Ingredient (In Each Tablet)

Acetaminophen USP, 325 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:headachemuscular achesbackacheminor pain of arthritisthe common coldtoothachepremenstrual or menstrual crampstemporarily reduces fever

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if
  • Adult takes more than 4,000 mg in 24 hours, which is the maximum daily amountchild takes more than 5 tablets in 24 hours, which is the maximum daily amounttaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks while using this product

Other Safety Information

  • Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
  • Skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.

Otc - Do Not Use

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.

Otc - Ask Doctor

Ask a doctor before use if the user has liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Otc - Stop Use

  • Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adultspain gets worse or lasts more than 5 days in childrenfever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese 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. 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 take more than directed (see overdose warning)adults and children 12 years and overtake 2 tablets every 4-6 hours while symptoms last, not more than 12 tablets in 24 hourschildren 6 to 11 yearstake 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hourschildren under 6 yearsdo not use

Other Information

  • Store at 15° to 30°C (59° to 86°F)

Inactive Ingredients

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

* Please review the disclaimer below.