FDA Label for Dollar General Headache Powders

View Indications, Usage & Precautions

Dollar General Headache Powders Product Label

The following document was submitted to the FDA by the labeler of this product Dolgencorp, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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:
    • headache
    • toothache
    • menstrual cramps
    • muscular aches
    • minor arthritis pain
    • colds
    • temporarily 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:

  • hives
  • facial swelling
  • shock
  • asthma (wheezing)
  • 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 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 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 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 faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • any new symptoms appear
    • ringing in the ears or a loss of hearing occurs
    • These 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 mg
  • store below 25°C (77°F)

Inactive Ingredients



docusate sodium, fumaric acid, lactose monohydrate, potassium chloride


Questions Or Comments?



Reese Pharmaceutical 1-800-321-7178


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Headache Powders


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