NDC 72828-447 Acedif Plus

Acetaminophen, Diphenhydramine Hcl

NDC Product Code 72828-447

NDC Code: 72828-447

Proprietary Name: Acedif Plus 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, Diphenhydramine Hcl 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):
BLUE (C48333)
Shape: CAPSULE (C48336)
Size(s):
18 MM
Imprint(s):
P525
Score: 1

Code Structure
  • 72828 - Plus Distributors Llc
    • 72828-447 - Acedif Plus

NDC 72828-447-24

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 24 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Acedif Plus with NDC 72828-447 is a a human over the counter drug product labeled by Plus Distributors Llc. The generic name of Acedif Plus is acetaminophen, diphenhydramine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Plus Distributors Llc

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.


Acedif Plus 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 500 mg/1
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POVIDONE K30 (UNII: U725QWY32X)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TALC (UNII: 7SEV7J4R1U)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)

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: Plus Distributors Llc
Labeler Code: 72828
FDA Application Number: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 02-01-2019 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.

Acedif Plus Product Label Images

Acedif Plus 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 (In Each Caplet)

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Purpose

Pain relieverNighttime sleep-aid

Uses

Temporary relief of occasional headaches and minor aches and pains accompanying sleeplessness

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:more than 4000 mg of acetaminophen in 24 hours  with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may incluse: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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with other products containing diphenhydramine, even one used on skin in children under 12 years of ageif you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have

  • Liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarin taking sedatives or tranquilizers

When Using This Product

  • Drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery

Stop Use And Ask A Doctor If

  • Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days  fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health care professional before use.

Keep Out Of Reach Of Children.

Overdose warning: 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 for children even if you do not notice any signs or symptoms.

Directions

  • Do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.children under 12 years: do not use

Other Information

  • Store between 15- 30o C (59- 86o F)avoid high humidity and excessive heat

Inactive Ingredients

Carnauba wax*, croscarmellose sodium*, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate*, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, polyvinyl alcohol*, povidone K30, pregelatinized starch, purified water*, silicon dioxide*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide*contains one or more of these ingredients

Product Label

Acedif PLUS

* Please review the disclaimer below.

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