Goodys Powder
FDA Label NDC 63029-665

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Goodys (NDC 63029-665). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

Principal Display Panelgoody’s® Hangoverberry Citrus Boostaspirin (nsaid) /  Pain Reliever, Caffeine /alertness Aid16 Powder Stick Packs (Goodys Hangover 01)

Principal Display Panelgoody’s® Hangoverberry Citrus Boostaspirin (nsaid) / Pain Reliever, Caffeine /alertness Aid16 Powder Stick Packs (Goodys Hangover 01)

Principal Display Panelgoody’s® Hangoverberry Citrus Boostaspirin (nsaid) /  Pain Reliever, Caffeine /alertness Aid16 Powder Stick Packs (Goodys Hangover 02)

Principal Display Panelgoody’s® Hangoverberry Citrus Boostaspirin (nsaid) / Pain Reliever, Caffeine /alertness Aid16 Powder Stick Packs (Goodys Hangover 02)

Principal Display Panelgoody’s® Hangoverberry Citrus Boostaspirin (nsaid) /  Pain Reliever, Caffeine /alertness Aid16 Powder Stick Packs (Goodys Hangover 03)

Principal Display Panelgoody’s® Hangoverberry Citrus Boostaspirin (nsaid) / Pain Reliever, Caffeine /alertness Aid16 Powder Stick Packs (Goodys Hangover 03)

* Please review the disclaimer below.