NDC 70518-1855 Regular Strength Pain Relief

Acetaminophen

NDC Product Code 70518-1855

NDC Code: 70518-1855

Proprietary Name: Regular Strength Pain Relief Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
GC101
Score: 1

Code Structure
  • 70518 - Remedyrepack Inc.
    • 70518-1855 - Regular Strength Pain Relief

NDC 70518-1855-0

Package Description: 30 TABLET in 1 BLISTER PACK

NDC Product Information

Regular Strength Pain Relief with NDC 70518-1855 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Regular Strength Pain Relief is acetaminophen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Remedyrepack Inc.

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

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Regular Strength Pain Relief Active Ingredient(s)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipAbout 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.

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

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: part343 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-07-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Regular Strength Pain Relief Product Label Images

Regular Strength 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 Ingredients

Acetaminophen 325 mg

Purpose

Pain Reliever/Fever Reducer

Uses

  • Temporarily relieves minor aches and painstemporarily reduces fever

Warnings

  • Liver warning: This product contains acetaminophen.
  • The maximum daily dose of this product is 10 tablets
  • In 24 hours. Severe liver damage may occur if you take:
  • More than 12 tablets (4,000 mg of acetaminophen)in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while usingthis product
  • 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.Do not usewith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.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 a doctor ifpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysnew symptom occurredness or swelling is presentThese could be signs of a serious condition.
  • If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. 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 directedadults and children 12 years and over: take 2 tablets every 4-6 hours, as needed; not more than 10 tablets in 24 hourschildren under 12 years: ask a doctor

Other Information

  • Store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

Povidone, sodium starch glycolate, starch stearic acid.

* Please review the disclaimer below.

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