RU-21 HANGOVER RELIEF- aspirin, caffeine capsule

RU-21 HANGOVER RELIEF by

Drug Labeling and Warnings

RU-21 HANGOVER RELIEF by is a Otc medication manufactured, distributed, or labeled by RU-21. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

RU-21 HANGOVER RELIEF 
aspirin, caffeine capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73156-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	50 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM SUCCINATE HEXAHYDRATE (UNII: U16QOD6C4E)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73156-010-20	1 in 1 BOX	07/01/2019
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/01/2019

Labeler - RU-21 (093475272)