NDC 69676-0042 Genexa Infants Pain And Fever

Acetaminophen

NDC Product Code 69676-0042

NDC 69676-0042-9

Package Description: 1 BOTTLE in 1 CARTON > 59 mL in 1 BOTTLE

NDC Product Information

Genexa Infants Pain And Fever with NDC 69676-0042 is a a human over the counter drug product labeled by Genexa Inc.. The generic name of Genexa Infants Pain And Fever is acetaminophen. The product's dosage form is suspension and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 307668.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

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.

Genexa Infants Pain And Fever 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.


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.

  • BLUEBERRY (UNII: 253RUG1X1A)
  • AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)
  • WATER (UNII: 059QF0KO0R)
  • CITRUS FRUIT (UNII: XDK00Z8012)

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: Genexa Inc.
Labeler Code: 69676
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: 06-24-2021 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.

Genexa Infants Pain And Fever Product Label Images

Genexa Infants Pain And Fever 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

Keep outer package for complete product informationDrug Facts

Bottle is safety sealed. DO NOT use if bottle seal is disturbed or missing.Certified B CorporationCertified Gluten-FreeCERTIFIED VEGANPatent PendingDistributed by: Genexa Inc., Atlanta, GA 30318genexa.com

Made in the USA with globally sourced ingredientsR-20210427NDC 69676-0042-9

Otc - Active Ingredient

Active ingredient (in each 5 mL)Acetaminophen 160 mg

Otc - Purpose

PurposePain reliever/fever reducer

Indications & Usage

  • Uses temporarily reduces fever and relieves minor aches and pains due to:the common coldheadachetoothacheflusore throat

Warnings

  • WarningsLiver 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 amountwith other drugs containing acetaminophenAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
  • Skin reddeningblistersrashIf 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.

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 your child has liver disease

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product, do not exceed recommended dose (see overdose warning)

Otc - Stop Use

  • Stop use and ask a doctor ifpain gets worse or lasts more than 5 daysfever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

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). Prompt medical attention is critical even if you do not notice any signs or symptoms.

Dosage & Administration

  • Directionsthis product does not contain directions or complete warnings for adult usedo not give more than directed (see overdose warning)SHAKE WELL BEFORE USINGmL = milliliterfind right dose on chart below. If possible, use weight to dose; otherwise, use agepush air out of syringe. Insert syringe tip into the bottle openingflip bottle upside down. Pull white part of syringe to correct dosedispense liquid slowly into child's mouth, toward inner cheekrepeat dose every 4 hours while symptoms lastdo not give more than 5 times in 24 hoursreplace cap tightly to maintain child-resistant packagingAttention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.
  • WeightAgeDoseunder 24 lbs.under 2 yearsask a doctor24-35 lbs.2-3 years5 mL

Storage And Handling

Other informationstore between 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredients organic agave syrup, organic blueberry flavor, natural citrus extract, non-GMO flavor, purified water

Otc - Questions

Questions?1-855-436-3921

* Please review the disclaimer below.