Label: GOODYS EXTRA STRENGTH HEADACHE MIXED FRUIT BLAST- acetaminophen, aspirin, and caffeine powder
- NDC Code(s): 63029-664-04, 63029-664-24
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated April 9, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredients
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.
▪ 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.
▪ store below 25°C (77°F)
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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)