NDC 57896-180 Pain Relief

Acetaminophen

NDC Product Code 57896-180

NDC Product Information

Pain Relief with NDC 57896-180 is a a human over the counter drug product labeled by Geri-care Pharmaceutical Corp. The generic name of Pain Relief 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.

Pain Relief 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)

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: Geri-care Pharmaceutical Corp
Labeler Code: 57896
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: 12-01-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 09-30-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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".

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Information for Patients

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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Pain Relief Product Label Images

Pain Relief 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 (Per Teaspoonful = 5 Ml)

Acetaminophen 160 mg

Purpose

Pain reliever/Fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:headachemuscular achesbackacheminor pain of arthritis the common coldtoothachepremenstrual and menstrual cramps. Temporarily reduces fever.

Liver Warning:

  • This product contains acetaminophen.Severe liver damage may occur if adult takes more than 6 doses in 24 hours, which is the maximum daily amountchild takes more than 5 doses in 24 hours, which is the maximum daily amounttaken with other drugs containing acetaminophenadults has 3 or more alcoholic drinks everyday while using this product

Do Not Use

  • With any other drug containing acetaminophen (prescription or non-prescription). 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

Otc - Ask Doctor

  • Ask a doctor before use if the user has a liver diseaseis on a sodium restricted diet

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

Stop Use And Ask A Doctor If

  • Pain 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

If pregnant or breastfeeding, ask a health professional before use.
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 even if you do not notice any signs or symptoms.

Directions

  • Find right dose on chart below. If possible, use weight to dose; otherwise, use age.dosage may be repeated every 4 hours, or as directed by a doctordo not use more than 5 times in 24 hoursWeight (lbs.)Age (yrs.)Dose (tsp or mL)under 24under 2consult physician24-352-31 tsp (5 mL)36-474-51½ tsp (7.5 mL)48-596-82 tsp (10 mL)60-719-102½ tsp (12.5 mL)72-95113 tsp or (15 mL)over 9512 to adult4 tsp (20 mL)

Other Information

  • Each teaspoon (5 mL) contains: sodium 7 mg
  • Store at room temperature 15º - 30ºC (59º - 86ºF)Protect from Freezing.Protect from Light.for institutional use only

Inactive Ingredients

Citric acid, FD&C red # 40, flavor, glycerin, PEG 400, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.

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