RU-21 HANGOVER RELIEF- aspirin, caffeine capsule 
RU-21

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.

----------

RU-21 HANGOVER RELIEF

Drug Facts

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:

Label

RU-21 HANGOVER RELIEF 
aspirin, caffeine capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73156-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE50 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM SUCCINATE HEXAHYDRATE (UNII: U16QOD6C4E)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73156-010-201 in 1 BOX07/01/2019
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/01/2019
Labeler - RU-21 (093475272)

Revised: 6/2019
Document Id: 8bda2451-a064-de63-e053-2a95a90aa1cf
Set id: ebba9ac5-39f2-44ba-a391-44d8fce7f70b
Version: 1
Effective Time: 20190621
 
RU-21