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Headache relief extra strength - Medication Information

Product NDC Code 55319-625
Drug Name

Headache relief extra strength

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]
Active Ingredients
Acetaminophen 250 mg/1
Aspirin 250 mg/1
Caffeine 65 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 308297
Application Number M013
Labeler Name Family Dollar (FAMILY WELLNESS)
Packages
Package NDC Code Description
55319-625-10 1 bottle, plastic in 1 box (55319-625-10) / 100 tablet in 1 bottle, plastic
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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)* Caffeine 65 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 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; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients carnauba wax**, colloidal silicon dioxide, corn starch, hypromellose, microcrystalline cellulose, mineral oil**, polyethylene glycol**, povidone, sodium starch glycolate**, stearic acid, talc**, titanium dioxide **contains one or more of these ingredients

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 toothache premenstrual and menstrual cramps

Purpose

Information about the drug product’s indications for use.
Purposes Pain reliever Pain reliever Pain reliever aid

Spl product data elements

Usually a list of ingredients in a drug product.
Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TALC TITANIUM DIOXIDE TCL370;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 COMPARE TO THE ACTIVE INGREDIENTS OF EXCEDRIN® EXTRA STRENGTH† EXTRA STRENGTH HEADACHE RELIEF Acetaminophen 250 mg - Pain reliever Aspirin (NSAID) 250mg - Pain reliever Caffeine 65 mg - Pain reliever aid CAPLETS †This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY: MIDWOOD BRANDS, LLC 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 Package Label FAMILY WELLNESS Extra Strength Headache Relief Acetaminophen 250 mg, Aspirin 250 mg (NSAID)*, Caffeine 65 mg, *nonsteroidal anti-inflammatory drug

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 asthma you are taking a diuretic you have a history of stomach problems, such as heartburn 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, or arthritis taking any other drug, or are under a doctor’s care for any serious condition

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. 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.

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 1- 877-753-3935 Monday-Friday 9AM-5PM EST

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. any new symptoms appear 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 pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days painful area is red or swollen these could be signs of a serious condition.

Pregnancy or breast feeding

Pregnancy or Breast feeding
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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store between 20º-25ºC (68º-77ºF)

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 : 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. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing) 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 heartbeat. 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 a doctor before use if you have liver disease stomach bleeding warning applies to you you have asthma you are taking a diuretic you have a history of stomach problems, such as heartburn 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, or arthritis taking any other drug, or are under a doctor’s care for any serious condition Stop use and ask doctor if an allergic reaction occurs. Seek medical help right away. any new symptoms appear 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 pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days painful area is red or swollen 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. 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.

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