NDC 69842-905 Acetaminophen, Acetaminophen Pm Extra Strength, Day And Night

Acetaminophen, Diphenhydramine Hcl

NDC Product Code 69842-905

NDC CODE: 69842-905

Proprietary Name: Acetaminophen, Acetaminophen Pm Extra Strength, Day And Night What 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 What 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.

NDC Code Structure

  • 69842 - Cvs Pharmacy

NDC 69842-905-12

Package Description: 1 KIT in 1 PACKAGE, COMBINATION * 50 TABLET in 1 BOTTLE * 50 TABLET in 1 BOTTLE

NDC Product Information

Acetaminophen, Acetaminophen Pm Extra Strength, Day And Night with NDC 69842-905 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Acetaminophen, Acetaminophen Pm Extra Strength, Day And Night is acetaminophen, diphenhydramine hcl. The product's dosage form is kit and is administered via form.

Labeler Name: Cvs Pharmacy

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SHELLAC (UNII: 46N107B71O)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • AMMONIA (UNII: 5138Q19F1X)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
  • GELATIN (UNII: 2G86QN327L)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SHELLAC (UNII: 46N107B71O)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cvs Pharmacy
Labeler Code: 69842
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: 02-18-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Acetaminophen, Acetaminophen Pm Extra Strength, Day And Night Product Label Images

Acetaminophen, Acetaminophen Pm Extra Strength, Day And Night 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 Gelcap)

Acetaminophen 500 mg

Acetaminophen 500 mgDiphenhydramine HCl 25 mg

Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:headachethe common coldbackacheminor pain of arthritistoothache muscular achespremenstrual and menstrual crampstemporarily reduces fever

Temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 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.

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 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

  • If you are allergic to acetaminophen or any of the inactive ingredients in this productwith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • With any other product containing diphenhydramine, even one used on skinin children under 12 years of agewith any other drug containing acetaminophen (prescription or nonprescription). 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 inactives ingredients in this product

Ask A Doctor Before Use If You Have

Liver disease.

  • A breathing problem such as emphysema or chronic bronchitisliver diseasedifficulty in urination due to enlargement of the prostate gland glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

Taking the blood thinning drug warfarin.

  • Taking the blood thinning drug warfarintaking sedatives or tranquilizers

Stop Use And Ask A Doctor If

  • New symptoms occurpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is presentThese could be signs of a serious condition.

  • Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.new symptoms occurredness or swelling is presentpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysThese could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 overtake 2 gelcaps every 6 hours while symptoms lastdo not take more than 6 gelcaps in 24 hours, unless directed by a doctordo not take for more than 10 days unless directed by a doctorchildren under 12 years: ask a doctor

  • Do not take more than directedadults and children 12 years and overtake 2 gelcaps at bedtimedo not take more than 2 gelcaps of this product in 24 hourschildren under 12 years: do not use

Other Information

  • Store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)avoid high humiditysee end flap for expiration date and lot number

  • Store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)avoid high humiditysee end flap for expiration date and lot number

Inactive Ingredients

Croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

When Using This Product

  • Drowsiness will occuravoid alcoholic beveragesdo not drive a motor vehicle or operate machinery

* Please review the disclaimer below.