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| Product NDC Code | 76168-119 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain relief pm |
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| Type | Brand | ||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 1092189 | ||||
| Application Number | part343 | ||||
| Labeler Name | Velocity Pharma | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each tablet) Acetaminophen 500mg Diphenhydramine HCl 25mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions do not exceed recommended dose 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, purified water, Sodium metabisulfite, Sodium starch glycolate, stearic acid, Titanium Dioxide, Talc
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Purpose
Information about the drug product’s indications for use.Purpose pain reliever/fever reducer Nighttime sleep aid
Spl product data elements
Usually a list of ingredients in a drug product.Pain Relief PM Acetaminophen PM SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POVIDONE SODIUM METABISULFITE STEARIC ACID TITANIUM DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC POLYETHYLENE GLYCOL 1000 ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE P525
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC: 76168-119-25 50 COUNT PM 50ct
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other Information store at 25 °C (77°F) excursions permitted between 15-30°C(59-86°F) do not use if imprinted safety seal under cap is broken or missing this product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol PM
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If pregnant or breast-feeding, ask a health professional before use.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments Call toll free 1-855-314-1850
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using this product Overdose warning : Taking more than recommended dose (overdose) may cause liver damage. In case of 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. do not use with any other drug containing acetaminophen (prescription or not prescription). 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 With other products containing diphenhydramine, even one used on skin. ask a doctor before use if you have liver disease asthma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland galucoma ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedative or tranquilizers. When using this product avoid alcoholic drinks do not drive a motor vehicle or operate machinery, this product will cause drowsiness Stop use and ask a doctor if: 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 occur.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API