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| Product NDC Code | 72090-006 | ||||
|---|---|---|---|---|---|
| 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 | ||||
| Application Number | M013 | ||||
| Labeler Name | Pioneer Life Sciences, LLC | ||||
| 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 Ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine 25 mg
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 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 in 24 hours unless directed by a doctor ■ children under 12 years do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: FD & C Blue # 1, FD & C Blue # 2, Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene glycol 400, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearic Acid Powder, Titanium Dioxide.
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: temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Purpose
Information about the drug product’s indications for use.Purpose Acetaminophen 500 mg ....................................................................................................................................Pain reliever Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid
Spl product data elements
Usually a list of ingredients in a drug product.Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ACETAMINOPHEN ACETAMINOPHEN FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE Magnesium Stearate POLYETHYLENE GLYCOL 400 STARCH, CORN POVIDONE, UNSPECIFIED STEARIC ACID Titanium Dioxide None
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.PL0035-Rev 01 Pain Relief PM- 375ct - Elysium 08.02.2023_page-0001
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.This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol® Extra Strength Tablets. Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln Suite A, East Brunswick, NJ 08816
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have: ■ liver disease ■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland.
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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 ■ 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.
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 Overdose warning: In case of overdose, get medical help or contact Poison Control (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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information: store at 20°-25°C (68°-77°F) do not use if foil or inner seal is broken or missing
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 1-732-698-5070 Monday through Friday 9am to 5pm EST or visit www.pioneerlifesciences.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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. These could be signs of a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product ■ drowsiness will occur ■ avoid alcoholic drinks ■ do not drive a motor vehicle or operate machinery.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use.
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 4,000 mg of acetaminophen in 24 hrs ■ 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.
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