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| Product NDC Code | 11673-305 | ||||||
|---|---|---|---|---|---|---|---|
| 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, COATED | ||||||
| RxCUI drug identifier | 308297 | ||||||
| Application Number | part343 | ||||||
| Labeler Name | TARGET CORPORATION | ||||||
| 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.ACETAMINOPHEN 250 MG - ASPIRIN 250 MG (nsaid*) CAFFEINE 65 MG - * NONSTEROIDAL ANIT-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.DO NOT USE MORE THAN DIRECTED - 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.STEARIC ACID MINERAL OIL SILICON DIOXIDE HYPROMELLOSES MICROCRYSTALLINE CELLULOSE STARCH, CORN POVIDONE CARNAUBA WAX TITANIUM DIOXIDE SODIUM STARCH GLYCOLATE
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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.TEMPORARILY RELIEVES MINOR ACHES AND PAINS DUE TO: headache - a cold - arthritis - muscular aches - toothache - premenstrual and 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-CAFFEINE CAFFEINE CAFFEINE ACETAMINOPHEN ACETAMINOPHEN TITANIUM DIOXIDE CARNAUBA WAX ASPIRIN ASPIRIN POVIDONE SODIUM STARCH GLYCOLATE TYPE A CORN MINERAL OIL SILICON DIOXIDE HYPROMELLOSES MICROCRYSTALLINE CELLULOSE STARCH, CORN STEARIC ACID TCL370 CAPLET
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.100CT NDC 305
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 (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
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 chickenpox 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 (sneezing) shock 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) 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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heartbeat.
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