GOODYS EXTRA STRENGTH HEADACHE MIXED FRUIT BLAST- acetaminophen, 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):                                             
Acetaminophen 325 mg 
Aspirin (NSAID*) 500 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever
Pain reliever
Pain reliever aid

Uses

Temporarily relieves minor aches and pains due to:

      headache                   minor arthritis pain

      muscular aches             colds

      backache                   toothache

      menstrual cramps

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).
Acetaminophen may cause severe skin reactions. Symptoms may include: ▪ skin reddening ▪ blisters ▪ rash. If a skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
▪ more than 4 powders in 24 hours, which is the maximum daily amount
▪ with other drugs containing acetaminophen
▪ 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains a 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: This product contains caffeine. Limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do not use

▪ if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

▪ you have liver disease
▪ 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
▪ the blood thinning drug warfarin

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
▪ 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 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.

Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

▪ do not take more than directed (see overdose warning)
▪ adults and children 12 years 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
▪ store below 25°C (77°F)

Inactive ingredients

colloidal silicon dioxide, flavors, guar gum, mannitol, microcrystalline cellulose, sucralose

Questions? 
1-866-255-5197 goodyspowder.com

PRINCIPAL DISPLAY PANEL

Goody’s Mixed Fruit Blast
Acetaminophen/ Aspirin (NSAID)/ Caffeine
Pain reliever/ Pain Reliever Aid

INGREDIENTS AND APPEARANCE

GOODYS  EXTRA STRENGTH HEADACHE MIXED FRUIT BLAST
acetaminophen, aspirin, and caffeine powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-664
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	500 mg

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

Product Characteristics
Color		Score
Shape		Size
Flavor	FRUIT (Mixed Fruit)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-664-04	4 in 1 CARTON; Type 0: Not a Combination Product	08/01/2015
2	NDC: 63029-664-24	24 in 1 CARTON; Type 0: Not a Combination Product	08/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	08/01/2015

Labeler - Medtech Products Inc. (122715688)