NDC 0904-6731 Acetaminophen, Diphenhydramine Hydrochloride

Acetaminophen, Diphenhydramine Hydrochloride

  1. Labeler Index
  2. Major Pharmaceuticals
  3. NDC: 0904-6731 Acetaminophen, Diphenhydramine Hydrochloride

NDC Product Code 0904-6731

NDC CODE: 0904-6731

Proprietary Name: Acetaminophen, Diphenhydramine Hydrochloride 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 Hydrochloride 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: OVAL (C48345)
Size(s):
17 MM
Imprint(s):
CPC752
Score: 1

NDC Code Structure

  • 0904 - Major Pharmaceuticals
    • 0904-6731 - Acetaminophen, Diphenhydramine Hydrochloride

NDC 0904-6731-51

Package Description: 1 BOTTLE in 1 CARTON > 50 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Acetaminophen, Diphenhydramine Hydrochloride with NDC 0904-6731 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Acetaminophen, Diphenhydramine Hydrochloride is acetaminophen, diphenhydramine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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 Hydrochloride 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.
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • POVIDONE K30 (UNII: U725QWY32X)
  • TRIACETIN (UNII: XHX3C3X673)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.
  • 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: Major Pharmaceuticals
Labeler Code: 0904
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: 12-26-2018 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.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)
Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]

* Please review the disclaimer below.

Acetaminophen, Diphenhydramine Hydrochloride Product Label Images

Acetaminophen, Diphenhydramine Hydrochloride 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

Drug Facts

Active ingredients (in each caplet) Acetaminophen 500 mgDiphenhydramine HCl 25 mg

Otc - Purpose

PurposePain relieverNighttime sleep-aid

Uses

Temporary 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 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 productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.

Otc - Do Not Use

Do not use■ with any other product containing diphenhydramine, even one used on skin■ in children under 12 years of age■ 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

Otc - Ask Doctor

Ask a doctor before use if you have■ liver disease■ a breathing problem such as emphysema or chronic bronchitis■ difculty in urination due to enlargement of the prostate gland■ glaucoma

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are■ taking the blood thinning drug warfarin■ taking sedatives or tranquilizers

Otc - When Using

When using this product■ avoid alcoholic beverages■ do not drive a motor vehicle or operate machinery■ drowsiness will occur

Otc - Stop Use

Stop use and ask a doctor if■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. ■ new symptoms occur■ redness or swelling is present■ pain gets worse or lasts more than 10 days■ fever gets worse or lasts more than 3 daysThese 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.

Overdosage

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 at room temperature

Inactive Ingredient

Croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide and triacetin

Other

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGDistributed by:MAJOR® PHARMACEUTICALS17177 N Laurel Park Drive, Suite 233Livonia, MI 48152

* Please review the disclaimer below.