NDC 73921-026 L-oral Paracetamol Syrup

Paracetamol

NDC Product Code 73921-026

NDC 73921-026-04

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

L-oral Paracetamol Syrup with NDC 73921-026 is a a human over the counter drug product labeled by Global Pharma Healthcare Private Limited. The generic name of L-oral Paracetamol Syrup is paracetamol. The product's dosage form is syrup and is administered via oral form.

Labeler Name: Global Pharma Healthcare Private Limited

Dosage Form: Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.

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.

L-oral Paracetamol Syrup 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 160 mg/5mL

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.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SORBITOL (UNII: 506T60A25R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • POVIDONE K30 (UNII: U725QWY32X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • WATER (UNII: 059QF0KO0R)

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: Global Pharma Healthcare Private Limited
Labeler Code: 73921
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: 04-01-2021 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: 12-31-2022 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 - NO 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.

L-oral Paracetamol Syrup Product Label Images

L-oral Paracetamol Syrup 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

Paracetamol 160 mg

Purpose

Pain reliever - Fever reducer

Inactive Ingredients

Artificial flavour, Methylparaben, Propylparaben, Potassium sorbate, Citric Acid Monohydrate, Sorbitol, Propylene glycol, Sucralose, Povidone K30, Glycerin, FD&C Red #40, D&C Red #33 & Purified water.

Uses

Temporarily relieves minor aches and pains due to:• The common cold • Flu • Headache • Sore throat • Toothache • Temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:  • More than 5 doses in 24 hours, which is the maximum daily amount  • With other drugs containing acetaminophenAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:  • Skin reddening  • Blisters  • RashIf a skin reaction occurs, stop use and seek medical help right away.Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.Do not use  • With any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist  • If your child is allergic to acetaminophen or any of the inactive ingredients in this productAsk a doctor before use if your child has liver diseaseAsk a doctor or pharmacist before use if your child is taking the blood thinning drug warfarinWhen using this product, do not exceed recommended dose (see overdose warning)Stop use and ask a doctor if• Pain gets worse or last for more than 5 days  • Fever gets worse or last for more than 3 days  • New symptoms occur  • Redness or swelling is presentThese could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of the 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

• This product does not contain directions or complete warnings for adult use • Find right dose on chart. If possible, use weight to dose; otherwise, use age • mL = milliliter • If needed, repeat dose every 4 hours • Do not use more than 5 doses in 24 hours • Use enclosed dosing cup only. Do not use any other device Weight Age Dose under 24 lbs Under 2 years Ask a doctor 24 to 35 lbs  2 to 3 years  5mL 36 to 47 lbs 4 to 5 years 7.5mL 48 to 59 lbs  6 to 8 years  10mL 60 to 71 lbs  9 to 10 years  12.5mL 72 to 95 lbs  11 years  15mL

Other Information

• TAMPER EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is cut, torn, broken, or missing.• Store at 20°- 25°C (68° - 77°F)• This product is not the same concentration as Infants' Drops. For accurate dosing, follow the dosing instructions on this label.

* Please review the disclaimer below.