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| Product NDC Code | 63029-053 | ||||||||
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| Drug Name | Percogesic original strength |
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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, COATED | ||||||||
| RxCUI drug identifier | 1052462, 1052466 |
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| Application Number | M013 | ||||||||
| Labeler Name | Medtech Products Inc. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Percogesic Original Strength
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdose warning : Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (in each tablet) Acetaminophen 325 mg
Active Ingredients (in each tablet) Diphenhydramine HCl 12.5 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 exceed recommended dosage. Adults and children 12 years and older: take 2 tablets every 4-6 hours. Maximum daily dose is 8 tablets. Children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Croscarmellose Sodium, FD&C Yellow #6 Lake, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Pregelatinized Starch, Silica, Sodium Starch Glycolate and Stearic Acid
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 for temporary relief of minor aches and pains due to: headache backache muscular aches arthritis pain colds flu fever toothache premenstrual and menstrual cramps Temporarily relieves runny nose sneezing itchy nose and throat
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer
Purpose Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Percogesic Original Strength Acetaminophen and Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED TALC CELLULOSE, MICROCRYSTALLINE LIGHT MINERAL OIL POLYETHYLENE GLYCOL 400 SILICON DIOXIDE STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN POVIDONE K30 Percogesic
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.PRINCIPAL DISPLAY PANEL ORIGINAL STRENGTH Percogesic ® Acetaminophen/Diphenhydramine HCl Aspirin-Free, Pain Reliever, Fever Reducer/ Antihistamine 5 0 COATED TABLETS PRINCIPAL DISPLAY PANEL FAST ACTING ORIGINAL STRENGTH Percogesic® Acetaminophen/Diphenhydramine for ENCHANCED RELIEF of PAIN Aspirin-Free, Pain Reliever, Fever Reducer/ Antihistamine See new warnings information. 90 EASY TO SWALLOW COATED TABLETS
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.Drug Facts
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 have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma
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 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 the reach of children.
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 controlled room temperature 15°-30°C (59°-86°F) avoid excessive heat
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-443-4908
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 pain persists for more than 10 days fever persists for more than 3 days (unless directed by a doctor) condition worsens or new symptoms occur redness or swelling is present. These may 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 marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may cause drowsiness may cause excitability, especially in children be careful driving a motor vehicle or operating machinery
Pregnancy or breast feeding
Pregnancy or Breast feedingI f you are pregnant or breast-feeding , ask a health care 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 8 tablets in 24 hours, which is the maximum daily amount 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 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 if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor or pharmacist before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged 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 marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may cause drowsiness may cause excitability, especially in children be careful driving a motor vehicle or operating machinery Stop use and ask a doctor if pain persists for more than 10 days fever persists for more than 3 days (unless directed by a doctor) condition worsens or new symptoms occur redness or swelling is present. These may be signs of a serious condition. I f you are pregnant or breast-feeding , ask a health care professional before use. Keep out of the reach of children.
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