NDC 62207-188 Acetaminophen

Acetaminophen

NDC Product Code 62207-188

NDC Code: 62207-188

Proprietary Name: Acetaminophen 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.

Non-Proprietary Name: Acetaminophen What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Product Characteristics
Color(s):
WHITE (C48325)
Shape: CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
G650
Score: 1

Code Structure
  • 62207 - Granules India Limited
    • 62207-188 - Acetaminophen

NDC 62207-188-51

Package Description: 1 BOTTLE in 1 CARTON > 10 TABLET, EXTENDED RELEASE in 1 BOTTLE

NDC Product Information

Acetaminophen with NDC 62207-188 is a a human over the counter drug product labeled by Granules India Limited. The generic name of Acetaminophen is acetaminophen. The product's dosage form is tablet, extended release and is administered via oral form.

Labeler Name: Granules India Limited

Dosage Form: Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.

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 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 650 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.

  • HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POVIDONE K30 (UNII: U725QWY32X)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

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.

Product Labeler Information

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

Labeler Name: Granules India Limited
Labeler Code: 62207
FDA Application Number: ANDA211544 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 04-18-2019 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 Product Label Images

Acetaminophen 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

Active Ingredient (In Each Caplet)

Acetaminophen USP,  650 mg

Purpose

Pain reliever/fever reducer

Uses

For


Arthritis Pain label • temporarily relieves minor aches and pains due to:


    • minor pain of arthritis


    • muscular aches


    • backache


    • premenstrual and menstrual cramps


    • the common cold


    • headache


    • toothache


• temporarily reduces fever


For


Muscle Aches & Pain label • temporarily relieves minor aches and pains due to:


    • muscular aches


    • backache


    • minor pain of arthritis


    • toothache


    • premenstrual and menstrual cramps


    • headache


    • the common cold


• temporarily reduces fever

Warnings

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


• more than 6 caplets in 24 hours, which is the maximum daily amount


• with other drugs containing acetaminophen


• 3 or more alcoholic drinks everyday while using this product


Allergy alert: acetaminophen may cause severe skin reactions


Symptoms may include:


• skin reddening


• blisters 


• rash


If a skin reaction occurs, stop use and seek medical help right away

Do Not Use

• with any other drugs 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 Doctor If

• pain gets worse or lasts more than 10 days


  • fever gets worse or lasts more than 3 days


  • new symptoms occur


  • redness or swelling is present


These could be signs of a serious condition.

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children

Overdose warning: 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

For Arthritis Pain Label • 


do not take more than directed (see overdose warning) adults • take 2 caplets every 8 hours with water


 • swallow whole; do not crush, chew, split or dissolve


 • do not take more than 6 caplets in 24 hours


 • do not use for more than 10 days unless directed by a doctor 


 under 18 years


 of age


 • ask a doctor For Muscle Ache and Pain label


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


 adults and children


12 years of age and over


 • take 2 caplets every 8 hours with water


 • swallow whole; do not crush, chew, split or dissolve


 • do not take more than 6 caplets in 24 hours


 • do not use for more than 10 days unless directed by a doctor


 children under


12 years


 • do not use

Other Information

• store between 20-25°C (68-77°F)


• do not use if foil inner seal is broken or missing.

Inactive Ingredients

Hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

* Please review the disclaimer below.

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