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Product NDC Code | 46122-456 | ||||||
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Drug Name | Pain relief pm |
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Type | Brand | ||||||
Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC] |
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Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | TABLET, FILM COATED | ||||||
RxCUI drug identifier | 1593110 | ||||||
Application Number | M013 | ||||||
Labeler Name | Amerisource Bergen | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Diphenhydramine citrate 38 mg *nonsteroidal anti-inflammatory drug
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, with a full glass of water 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 corn starch, crospovidone, FD&C blue #1 aluminum lake, hypromellose, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polydextrose, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium sulfate, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate
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 the temporary 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 Pain reliever Nighttime sleep-aid
Spl product data elements
Usually a list of ingredients in a drug product.Pain Relief PM Acetaminophen, Aspirin, Diphenhydramine citrate ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE STARCH, CORN CROSPOVIDONE, UNSPECIFIED FD&C BLUE NO. 1 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POVIDONE, UNSPECIFIED SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO SODIUM SULFATE STEARIC ACID TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW ZINC STEARATE 674
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 GOOD NEIGHBOR PHARMACY ® Compare to Excedrin ® PM Headache active ingredients † NDC 46122-456-71 Pain Relief PM acetaminophen aspirin (NSAID) & diphenhydramine citrate Pain Reliever / Nighttime Sleep Aid • Caffeine free 50 Caplets ι • Non-habit forming Actual Size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING † This product is not manufactured or distributed by GSK Consumer Healthcare SARL, owner of the registered trademark Excedrin ® PM Headache. 50844 REV1121A67415 Distributed By AmerisourceBergen 1 West First Avenue Conshohocken, PA 19428 Questions or Concerns? www.mygnp.com GOOD NEIGHBOR PHARMACY BRAND PRODUCTS SATISFACTION GUARANTEED Good Neighbor Pharmacy 44-674 Good Neighbor Pharmacy 44-674
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 stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have glaucoma you have asthma you have difficulty in urination due to enlargement of the prostate gland you are taking a diuretic you have a breathing problem such as emphysema or chronic bronchitis you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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 a prescription drug for: diabetes gout arthritis any other drug, or are under a doctor's care for any serious condition sedatives or tranquilizers any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
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 if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer 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
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. In case of accidental 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.
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? 1-800-426-9391
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 an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days painful area is red or swollen new symptoms occur ringing in the ears or a loss of hearing occurs sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. 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 may occur do not drive a motor vehicle or operate machinery avoid alcoholic beverages
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
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 Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives shock facial swelling asthma (wheezing) Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. 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 Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] take more or for a longer time than directed have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug Do not use if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer 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 Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have glaucoma you have asthma you have difficulty in urination due to enlargement of the prostate gland you are taking a diuretic you have a breathing problem such as emphysema or chronic bronchitis you have high blood pressure, heart disease, liver cirrhosis, or kidney disease Ask a doctor or pharmacist before use if you are taking a prescription drug for: diabetes gout arthritis any other drug, or are under a doctor's care for any serious condition sedatives or tranquilizers any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer When using this product drowsiness may occur do not drive a motor vehicle or operate machinery avoid alcoholic beverages Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days painful area is red or swollen new symptoms occur ringing in the ears or a loss of hearing occurs sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of accidental 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.
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