NDC 0904-6731 Acetaminophen, Diphenhydramine Hydrochloride
Tablet, Film Coated Oral
Product Information
What is NDC 0904-6731?
The NDC code 0904-6731 is assigned by the FDA to the product Acetaminophen, Diphenhydramine Hydrochloride which is a human over the counter drug product labeled by Major Pharmaceuticals. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 0904-6731-51 1 bottle in 1 carton / 50 tablet, film coated in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Acetaminophen, Diphenhydramine Hydrochloride?
This product is used as PurposePain relieverNighttime sleep-aid. Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Product Characteristics
Color(s) | BLUE (C48333) |
Shape | OVAL (C48345) |
Size(s) | 17 MM |
Imprint(s) | CPC752 |
Score | 1 |
Product Packages
NDC Code 0904-6731-51
Package Description: 1 BOTTLE in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE
Price per Unit: $0.04781 per EA
Product Details
What are Acetaminophen, Diphenhydramine Hydrochloride Active Ingredients?
- ACETAMINOPHEN 500 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
- DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 - A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.
Acetaminophen, Diphenhydramine Hydrochloride Active Ingredients UNII Codes
- ACETAMINOPHEN (UNII: 362O9ITL9D)
- ACETAMINOPHEN (UNII: 362O9ITL9D) (Active Moiety)
- DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
- DIPHENHYDRAMINE (UNII: 8GTS82S83M) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1092189 - acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet
- RxCUI: 1092189 - acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet
- RxCUI: 1092189 - APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet
Acetaminophen, Diphenhydramine Hydrochloride Inactive Ingredients UNII Codes
- 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)
Pharmacologic Class(es)
* Please review the disclaimer below.
Patient Education
Acetaminophen
Acetaminophen is pronounced as (a set a mee' noe fen)
Why is acetaminophen medication prescribed?Diphenhydramine
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 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
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- DRUG FACTS
- OTC - PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Otc - Purpose
Purpose
Pain reliever
Nighttime 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 product
Allergy 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 days
These 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
Questions Or Comments?
Call (800) 616-2471
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 MISSING
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Package Label.Principal Display Panel
See New Warnings Information and Directions
NDC 0904-6731-51
MAJOR
Extra Strength Acetaminophen PM Caplets
Pain Reliever
Sleep Aid
Acetaminophen 500 mg and Diphenhydramine HCl 25 mg each
Compare to active ingredient of TYLENOL PM*
50 Caplets
* Please review the disclaimer below.