FDA Label for Goodys Hangover

View Indications, Usage & Precautions

Goodys Hangover Product Label

The following document was submitted to the FDA by the labeler of this product Medtech Products Inc.. 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.

Purposes



Aspirin (NSAID*) 1000 mg…………………………………......Pain reliever

Caffeine 150 mg……………………………….…………………Alertness aid 

*nonsteroidal anti-inflammatory drug


Uses



Temporarily relieves minor aches and pains due to:

  • hangover
  • headache
  • muscle aches
  • Helps restore mental alertness when experiencing fatigue or drowsiness associated with a hangover


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 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 non-prescription 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 heart beat.


Do Not Use



▪ for more than 2 days for a hangover unless directed by a doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a doctor.

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

▪ in children under 12 years of age


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 ▪ arthritis


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 stool

• have stomach pain that does not get better

• 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 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 (1-800-222-1222) right away.


Directions



Adults and children 12 years and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full 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: ask a doctor.


Other Information



Store below 25°C (77°F)


Inactive Ingredients



colloidal silicon dioxide, flavor, guar gum, mannitol, microcrystalline cellulose, sucralose, xylitol.


Questions?



1-866-255-5197 goodyspowder.com


Principal Display Panel



Goody’s® Hangover

Berry Citrus Boost

ASPIRIN (NSAID) / PAIN RELIEVER, CAFFEINE /ALERTNESS AID

16 powder stick packs


* Please review the disclaimer below.