NDC 55319-586 Headache Relief Extra Strength

Acetaminophen, Aspirin, Caffeine

NDC Product Code 55319-586

NDC Code: 55319-586

Proprietary Name: Headache Relief Extra Strength Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Aspirin, Caffeine Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Product Characteristics
Color(s):
WHITE (C48325 - GREEN)
Shape: CAPSULE (C48336)
Size(s):
13 MM
Imprint(s):
P
Score: 1

Code Structure
  • 55319 - Family Dollar (family Wellness)
    • 55319-586 - Headache Relief

NDC 55319-586-80

Package Description: 80 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Headache Relief Extra Strength with NDC 55319-586 is a a human over the counter drug product labeled by Family Dollar (family Wellness). The generic name of Headache Relief Extra Strength is acetaminophen, aspirin, caffeine. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Family Dollar (family Wellness)

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Headache Relief Extra Strength Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 250 mg/1
  • ASPIRIN 250 mg/1
  • CAFFEINE 65 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL CAPRYLOCAPRATE (UNII: U72Q2I8C85)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • MALTITOL (UNII: D65DG142WK)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POVIDONE (UNII: FZ989GH94E)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Family Dollar (family Wellness)
Labeler Code: 55319
FDA Application Number: part343 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-31-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Headache Relief Extra Strength Product Label Images

Headache Relief Extra Strength Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In Each Geltab)

Acetaminophen 250 mgAspirin 250 mg (NSAID)*Caffeine 65 mg*nonsteroidal anti-inflammatory drug

Purposes

Pain relieverPain relieverPain reliever aid

Uses

  • Temporarily relieves minor aches and pains due to:
  • Headache a cold arthritis muscular aches  toothache premenstrual and menstrual cramps

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 illnessAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddening blisters rashIf 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:adults 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 productStomach 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 directedCaffeine 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 appearyou experience any of the following signs of stomach bleeding
  • Feel faint vomit bloodhave bloody or black stoolshave stomach pain that does not get betterringing in the ears or loss of hearing occurspain gets worse or lasts for more than 10 daysfever gets worse or lasts for more than 3 dayspainful area is red or swollenThese 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.

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 geltabs 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

Other Information

  • Store between 20º-25ºC (68º-77ºF)

Inactive Ingredients

Black printing ink,corn starch, D&C yellow #10 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin,glycerin, glycerly caprylocaprate**, hydroxypropyl cellulose**, hydroxypropyl cellulose-low substituted, hypromellose**, iron oxide black, maltitol, polyvinyl alcohol**, povidone, purified water, sodium lauryl sulfate**, stearic acid, talc**, titanium dioxide**contains one or more of these ingredients

Package Label

FAMILY WELLNESS Extra Strength Headache Relief

* Please review the disclaimer below.

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