NDC 70518-0444 Plus Pharma Pain Reliever,fever Reducer

Acetaminophen

NDC Product Code 70518-0444

NDC 70518-0444-4

Package Description: 30 TABLET in 1 BLISTER PACK

NDC Product Information

Plus Pharma Pain Reliever,fever Reducer with NDC 70518-0444 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Plus Pharma Pain Reliever,fever Reducer 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 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.

Plus Pharma Pain Reliever,fever Reducer 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 325 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.

  • POVIDONE (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Remedyrepack Inc.
Labeler Code: 70518
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: 06-05-2017 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: 12-31-2021 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.

Plus Pharma Pain Reliever,fever Reducer 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 Tablet)

Acetaminophen 325 mg

Purposes

Pain reliever/fever reducer

Uses

  • For the temporary relief of minor aches and pains due to:HeadacheMuscular achesBackacheMinor pain of arthritis
  • The common coldToothachePremenstrual and menstrual crampsTemporarily reduces fever.

Warnings

  • Liver warning:
  • This product contains acetaminophen. Severe liver damage may occur if
  • Adult takes more than 12 tablets in 24 hours, which is the maximum daily amountchild takes more than 5 doses in 24 hourstaken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this productAllergy 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 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

Ask A Doctor Before Use If The User Has

Liver disease.

Ask A Doctor Or Pharmacist Before Use If The User Is

Taking the blood thinning drug warfarin.

Stop Use And Ask A Doctor If

  • Pain gets worse or lasts more than 10 days in adults and children Pain gets worse or lasts more than 5 days in children under 12 yearsFever gets worse or lasts more than 3 daysNew symptoms occurRedness or swelling is presentThese could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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. (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

  • Do not take more than directedAGEDOSEAdults and Children 12 years and overTake 2 tablets every 4 to 6 hours while symptoms lastDo not take more than 12 tablets in 24 hoursChildren 6 - 11 yearsTake 1 tablet every 4 to 6 hours while symptoms last Do not take more than 5 tablets in 24 hoursChildren under 6 yearsDo not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other Information

  • Do not use if imprinted Safety Seal under cap is broken or missingStore at room temperature

Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

* Please review the disclaimer below.