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| Product NDC Code | 29485-6486 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Extra strength headache relief |
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| Type | Brand | ||||||
| Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET | ||||||
| RxCUI drug identifier | 308297 | ||||||
| Application Number | M013 | ||||||
| Labeler Name | Lil' Drug Store Products, 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) Active ingredient (in each caplet) Purpose Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever Caffeine 65 mg Pain reliever aid
| Acetaminophen 250 mg | Pain reliever |
| Aspirin 250 mg (NSAID) | Pain reliever |
| Caffeine 65 mg | Pain reliever aid |
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 use more than directed (see OVERDOSE WARNING) drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, 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 relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual & menstrual cramps
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/Pain reliever aid
Spl product data elements
Usually a list of ingredients in a drug product.Extra Strength Headache Relief acetaminophen, aspirin, and caffeine SILICON DIOXIDE TALC MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED POVIDONE K30 STEARIC ACID STARCH, CORN ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE (capsule shaped, biconvex) S53
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- 25 Count Box COMPARE TO THE ACTIVE INGREDIENTS IN EXCEDRIN® EXTRA STRENGTH Extra Strength Headache Relief Acetaminophen Aspirin (NSAID) and Caffeine Pain Reliever/Fever Reducer 25 POUCHES 2 CAPLETS PER POUCH ES Headache Relief 25 count
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
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of EXCEDRIN® EXTRA STRENGTH tablets. Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404 Made in India
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 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 high blood pressure, heart disease, liver cirrhosis or kidney disease you are taking a diuretic you have asthma
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 any other drug containing an NSAID (prescription or nonprescription) a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition a blood thinning (anticoagulant) or steroid drug
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.
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 a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 1(800) 222-1222
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 1-888-333-9792
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 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 ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear These could be signs of a serious condition
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 during the last 3 months of 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 Each caplet contains: Magnesium 0.58 mg store at controlled room temperature 20º - 25º C (68º - 77º F) read all product information before using. Keep this box for important information
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 facial swelling asthma (wheezing) shock 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. Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets 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 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 had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Caffeine warning The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. 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. Ask 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 high blood pressure, heart disease, liver cirrhosis or kidney disease you are taking a diuretic you have asthma Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition a blood thinning (anticoagulant) or steroid drug Stop use and ask 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 ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear 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 during the last 3 months of 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 Overdose Warning In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 1(800) 222-1222
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