![GOODYS EXTRA STRENGTH HEADACHE MIXED FRUIT BLAST (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]](https://medic.hrt.org//dailymed/images/6cb758bf-5a50-46bb-96e7-65b810b12de0/goodys-extra-strength-headache-powder---mixed-frui-01.jpg)
| NDC | 63029-664-04, 63029-664-24 |
| Set ID | 6cb758bf-5a50-46bb-96e7-65b810b12de0 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Medtech Products Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purposes
- Uses
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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 productStomach 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 asthmaAsk a doctor or pharmacist before use if you are taking
▪ a prescription drug for diabetes, gout, or arthritis
▪ the blood thinning drug warfarinStop 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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GOODYS EXTRA STRENGTH HEADACHE MIXED FRUIT BLAST
acetaminophen, aspirin, and caffeine powderProduct 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)
