GOODYS HANGOVER- aspirin and caffeine powder

GOODYS by

Drug Labeling and Warnings

GOODYS by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts                                                                

Active ingredients (in each powder)

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

INGREDIENTS AND APPEARANCE

GOODYS  HANGOVER
aspirin and caffeine powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-665
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	150 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	1000 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GUAR GUM (UNII: E89I1637KE)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BERRY (Berry Citrus)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-665-16	16 in 1 CARTON; Type 0: Not a Combination Product	11/15/2019
2	NDC: 63029-665-24	24 in 1 CARTON; Type 0: Not a Combination Product	11/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	11/15/2019

Labeler - Medtech Products Inc. (122715688)