NDC 69842-308 Acetaminophen Diphenhydramine Hcl

Acetaminophen Diphenhydramine Hcl

NDC Product Code 69842-308

NDC Code: 69842-308

Proprietary Name: Acetaminophen Diphenhydramine Hcl 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.


Product Characteristics
Color(s):
GRAY (C48324 - ENCAPSULATED GRAY COLOR TABLETS WITH ONE RED OPAQUE AND ONE BLUE-GRAY OPAQUE HARD GELATIN SHELLS)
GRAY (C48324 - ENCAPSULATED GRAY COLOR TABLETS WITH DARK BLUE OPAQUE AND LIGHT BLUE OPAQUE HARD GELATIN SHELLS)
Shape: OVAL (C48345)
Size(s):
20 MM
Imprint(s):
G1;G3
Score: 1

Code Structure
  • 69842 - Cvs Pharmacy, Inc
    • 69842-308 - Acetaminophen Diphenhydramine Hcl

NDC 69842-308-10

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Acetaminophen Diphenhydramine Hcl with NDC 69842-308 is a a human over the counter drug product labeled by Cvs Pharmacy, Inc. The generic name of Acetaminophen Diphenhydramine Hcl is acetaminophen diphenhydramine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Cvs Pharmacy, 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.


Acetaminophen Diphenhydramine Hcl 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 500 mg/1
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 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.

  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • GELATIN (UNII: 2G86QN327L)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • AMMONIA (UNII: 5138Q19F1X)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TRIACETIN (UNII: XHX3C3X673)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
  • POVIDONE (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SHELLAC (UNII: 46N107B71O)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

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: Cvs Pharmacy, Inc
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: 01-29-2019 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: 12-31-2019 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 Diphenhydramine Hcl Product Label Images

Acetaminophen Diphenhydramine Hcl 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

Acetaminophen Gelcaps Active Ingredient

(in each Gelcap)Acetaminophen, USP 500 mg

Purpose

Pain reliever/fever reducer

Uses

■ temporarily relieves minor aches and pains due to:■ headache■ muscular aches■ backache■ minor pain of arthritis■ the common cold■ toothache■ premenstrual and menstrual cramps■ temporarily reduces fever

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

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:■ more than 4,000 mg of acetaminophen in 24 hours■ with other drugs containing acetaminophen■ 3 or more alcoholic drinks every day while using this product

This product contains acetaminophen. Severe liver damage may occur if you take■ more than 4,000 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 include:■ skin reddening■ blisters■ rashIf a skin reaction occurs, stop use and seek medical help right away.

Acetaminophen may cause severe skin reactions. Symptoms may include:■ skin reddening■ blisters■ rashIf 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■ if you have ever had an allergic reaction to this product or any of its ingredients

■ 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 any other product containing diphenhydramine, even one used on skin■ in children under 12 years of age■ if 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.

■ 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 the blood thinning drug warfarin■ taking sedatives or tranquilizers

Stop Use And Ask A Doctor If

■ pain gets worse or lasts more than 10 days■ fever gets worse or lasts more than 3 days■ new symptoms occur■ redness 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 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 occurThese 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 The Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Keep out of the reach of children.

Directions

■ do not take more than directedadults and children 12 years and over■ take 2 gelcaps every 6 hours while symptoms last■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor■ do not take more than 10 days unless directed by a doctorchildren under 12 years■ ask a doctor

■ do not take more than directed (see overdose warning)adults and children 12 years and over■ take 2 gelcaps at bedtime■ do not take more than 2 gelcaps of this product in 24 hourschildren under 12 years■ do not use

Other Information

■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature■ avoid high humidity■ see end panel for lot number and expiration date

■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.■ see end panel for lot number and expiration date

Inactive Ingredients

Ammonium hydroxide, black iron oxide, black iron oxide irradiated, colloidal silicon dioxide, croscarmellose sodium, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide.

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.

Acetaminophen Pm Gelcaps Active Ingredient

(in each gelcap)Acetaminophen, USP 500 mgDiphenhydramine HCl, USP 25 mg

Purposes

Pain relieverNighttime sleep aid

When Using This Product

■ drowsiness will occur■ avoid alcoholic drinks■ do not drive a motor vehicle or operate machinery

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 (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.

* Please review the disclaimer below.

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