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| Product NDC Code | 17714-133 | ||||
|---|---|---|---|---|---|
| Drug Name | Acetaminophen pm |
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| Type | Generic | ||||
| 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 | part341 | ||||
| Labeler Name | Advance Pharmaceutical Inc. | ||||
| 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 caplet) Acetaminophen 500 mg Diphenhydramine HCl 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 adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor 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 crosscarmellose sodium, FD&C blue # 1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, silicon dioxide, starch, stearic acid, 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 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 / Night time sleep aid
Spl product data elements
Usually a list of ingredients in a drug product.ACETAMINOPHEN PM ACETAMINOPHEN PM CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POVIDONE SILICON DIOXIDE STARCH, CORN STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE AP;133
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: 17714-133-50 – 50 COUNT CAPLETS 079fcfcb-figure-01 079fcfcb-figure-02
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 15-30 °C (59-86 °F)
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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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 631-981-4600 8.30 am- 4.30 pm ET, Monday-Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742
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 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other drug containing diphenhydramine, even one used on skin in children under 12 years of age Ask a doctor before use if the you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedative or tranquilizers when using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery 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. Any new symptoms appear redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days If pregnant or breast-feeding, ask a health professional before use.
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