Label: GOODYS HANGOVER- aspirin and caffeine powder
- NDC Code(s): 63029-665-04, 63029-665-16, 63029-665-24
- 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.
Drug Label Information
Updated July 17, 2020
If you are a consumer or patient please visit this version.
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- Active ingredients (in each powder)
- Purposes
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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).
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.
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INGREDIENTS AND APPEARANCE
GOODYS HANGOVER
aspirin and caffeine powderProduct 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:63029-665-04 4 in 1 CARTON; Type 0: Not a Combination Product 11/15/2019 2 NDC:63029-665-16 16 in 1 CARTON; Type 0: Not a Combination Product 11/15/2019 3 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)
