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NDC 00904-6731-51 Acetaminophen, Diphenhydramine Hydrochloride 500; 25 mg/1; mg/1 Details
Acetaminophen, Diphenhydramine Hydrochloride 500; 25 mg/1; mg/1
Acetaminophen, Diphenhydramine Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 00904-6731-51Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
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 also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 00904-6731-51Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 00904-6731 |
|---|---|
| Product ID | 0904-6731_d1151d77-f72b-5dfa-e053-2a95a90a90cd |
| Associated GPIs | 60309902200310 |
| GCN Sequence Number | 003699 |
| GCN Sequence Number Description | acetaminophen/diphenhydramine TABLET 500MG-25MG ORAL |
| HIC3 | B5S |
| HIC3 Description | ANALGESIC, NON-SAL.- 1ST GENERATION ANTIHISTAMINE |
| GCN | 70221 |
| HICL Sequence Number | 001861 |
| HICL Sequence Number Description | ACETAMINOPHEN/DIPHENHYDRAMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Acetaminophen, Diphenhydramine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Diphenhydramine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500; 25 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | Major Pharmaceuticals |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00904-6731-51 (00904673151)
| NDC Package Code | 0904-6731-51 |
|---|---|
| Billing NDC | 00904673151 |
| Package | 1 BOTTLE in 1 CARTON (0904-6731-51) / 50 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2018-12-26 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.04706 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | ACETAMINOPHEN PM CAPLET |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 786dbcd5-f5c2-4491-e053-2991aa0a3437 Details
Uses
SPL UNCLASSIFIED SECTION
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.
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
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
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
When using this product
■ avoid alcoholic beverages
■ do not drive a motor vehicle or operate machinery
■ drowsiness will occur
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.
Directions
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
acetaminophen, diphenhydramine hydrochloride tablet, film coated |
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| Labeler - Major Pharmaceuticals (191427277) |