FDA Label for Ru-21 Hangover Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH CAPSULE)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- STOMACH BLEEDING WARNING:
- ASK A DOCTOR BEFORE USE IF
- STOP USE AND ASK A DOCTOR IF
- WHEN USING THIS PRODUCT
- KEEP OUT OF REACH OF CHILDREN
- IF PREGNANT OR BREASTFEEDING
- ASK A DOCTOR OR PHARMACIST BEFORE USE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABELING:
Ru-21 Hangover Relief Product Label
The following document was submitted to the FDA by the labeler of this product Ru-21. 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 Capsule)
Aspirin 250 mg (NSAID*)
Caffeine 50 mg
*Nonsteroidal anti-inflammatory drug
Purpose
Pain Reliever
Alertness aid/Pain reliever aid
Uses
• for the temporary relief of minor aches and pains associated with a hangover
• helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover
• for temporary relief of headaches or body aches and pains
Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from chickenpox 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 a severe allergic reaction, which may include: • hives • asthma (wheezing) • facial swelling • shock
Do Not Use
• if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
• in children under 12 years of age
Stomach Bleeding Warning:
This product contains a nonsteroidal anti-inflammatory drug (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
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 • you have a sodium-restricted diet
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 stools, have stomach pain that does not get better
• pain lasts for more than 10 days or gets worse
• new symptoms occur
• redness or swelling is present
• ringing in the ears or a loss of hearing occurs
When Using This Product
• the recommended dose of this product contains caffeine. Limit the use of caffeine-containing medications, foods, or beverages because excess of caffeine may cause nervousness, irritability, irritability, sleeplessness, and occasionally rapid heartbeat.
• for occasional use only. 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 occur, consult a doctor.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breastfeeding
ask a health professional before use. It is especially important not to use aspiring 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.
Ask A Doctor Or Pharmacist Before Use
if you are taking a prescription drug for • diabetes • gout • arthritis
Directions
upon waking, take 2 capsules with 8-12 oz. of water do not exceed recommended dosage
Adults and children 12 years and over (up to 60 years of age): 2-3 capsules every 6 hours, as needed, or as directed by a doctor. Do not exceed 8 capsules in 24 hours
Adults 60 years and over: 2 tablets every 6 hours, as needed, or as directed by a doctor. Do not exceed 4capsules in 24 hours Children under 12 years: Do not use
Other Information
each capsule contains: sodium 20 mg store at room temperature (60–85°F). Protect from excessive heat.
Inactive Ingredients
Sodium succinate hexahydrate (Agixen™), Gelatin, Magnesium stearate
Questions Or Comments?
310-846-1122 (Mon-Fri / 10am-5pm PST)
Manufactured for /Distributed by:
RU-21, LLC 46-E Peninsula Center Suite 248 Rolling Hills Estates CA 90274 www.RU21.com
Package Labeling:
* Please review the disclaimer below.