NDC 55910-695 Dollar General Headache Powders

Aspirin And Caffeine

NDC Product Code 55910-695

NDC 55910-695-18

Package Description: 18 PACKET in 1 CARTON > 1 POWDER in 1 PACKET

NDC 55910-695-50

Package Description: 24 PACKET in 1 CARTON > 1 POWDER in 1 PACKET

NDC Product Information

Dollar General Headache Powders with NDC 55910-695 is a a human over the counter drug product labeled by Dolgencorp, Llc. The generic name of Dollar General Headache Powders is aspirin and caffeine. The product's dosage form is powder and is administered via oral form.

Labeler Name: Dolgencorp, Llc

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

Product Type: Human Otc Drug What 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.

Dollar General Headache Powders Active Ingredient(s)

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

  • CAFFEINE 65 mg/1
  • ASPIRIN 845 mg/1

Inactive Ingredient(s)

About 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.

  • DOCUSATE SODIUM (UNII: F05Q2T2JA0)
  • FUMARIC ACID (UNII: 88XHZ13131)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

Administration Route(s)

What 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

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dolgencorp, Llc
Labeler Code: 55910
FDA Application Number: part343 What 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. What 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: 03-31-2021 What 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: 12-31-2022 What 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 - NO What 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Dollar General Headache Powders Product Label Images

Dollar General Headache Powders 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 Ingredient

(in each powder)Aspirin (NSAID*) 845 mg*nonsteroidal anti-inflammatory drug

(in each powder)Caffeine 65 mg

Purpose

Pain reliever/fever reducer

Pain reliever aid

Uses

  • Temporarily relieves minor aches and pains due to:headachetoothachemenstrual crampsmuscular achesminor arthritis paincoldstemporarily reduces fever

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:hivesfacial swellingshockasthma (wheezing)Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if youare age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directedCaffeine warning: The recommended dose of this product contains about as much caffeine as a cup ocoffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this productbecause too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do Not Use

If you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Ask A Doctor Before Use If

  • Stomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking a diureticyou have asthma

Ask A Doctor Or Pharmacist Before Use If You Are

Taking a prescription drug for diabetes, gout, or arthritis

When Using This Product

Limit the use of caffeine-containing drugs, foods, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

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 faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betterpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is presentany new symptoms appearringing in the ears or a loss of hearing occursThese could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health care 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.

Directions

  • Adults and children 12 years of age and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid.do not take more than 4 powders in 24 hours unless directed by a doctor.children under 12 years of age: ask a doctor.

Other Information

  • Each powder contains: potassium 55 mgstore below 25ºC (77ºF)

Inactive Ingredients

Docusate sodium, fumaric acid, lactose monohydrate, potassium chloride

* Please review the disclaimer below.