FDA Label for Goodys Extra Strength
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH POWDER):
- PURPOSES
- USES
- WARNINGS:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS:
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
Goodys Extra Strength 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.
Active Ingredients (In Each Powder):
Acetaminophen 260 mg
Aspirin (NSAID*) 520 mg
Caffeine 32.5 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
- muscle aches • colds
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).
- 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
- 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.
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
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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 a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for 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
- each powder contains: potassium 51 mg
- store below 25°C (77°F)
Inactive Ingredient
lactose monohydrate, potassium chloride
Questions?
1-866-255-5197 weekdays or goodyspowder.com
Principal Display Panel
Goody’s
EXTRA STRENGTH
HEADACH POWDERS
FAST PAIN RELIEF
ACETAMINOPHEN
ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER/PAIN RELIEVER AID
2 POWDER STICK PACKS
Goody’s
EXTRA STRENGTH
HEADACH POWDER
ACETAMINOPHEN
ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER/PAIN RELIEVER AID
18 PACKS
* Please review the disclaimer below.