RU-21 HANGOVER RELIEF

Manufacturer
RU-21
Effective date
2019-06-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:49

Label at a glance#

ProductRU-21 HANGOVER RELIEF
Active ingredientASPIRIN, CAFFEINE
Label structure8 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients (In each capsule)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 250 mg (NSAID*)

Caffeine 50 mg

*Nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain Reliever

Alertness aid/Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

• 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:

SPL UNCLASSIFIED SECTION

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

OTC - ASK DOCTOR SECTION

• 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

OTC - STOP USE SECTION

• 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

OTC - WHEN USING SECTION

• 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking a prescription drug for • diabetes • gout • arthritis

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

each capsule contains: sodium 20 mg store at room temperature (60–85°F). Protect from excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sodium succinate hexahydrate (Agixen™), Gelatin, Magnesium stearate

Questions or Comments?

OTC - QUESTIONS SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2176259aspirin 250 MG / caffeine 50 MG Oral CapsulePSN1
2176259aspirin 250 MG / caffeine 50 MG Oral CapsuleSCD1
2176259ASA 250 MG / Caffeine 50 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
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9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
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9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73156-010-202023-01-30C16284748780-1f386c64a-2d02-0266-e053-dadaa90a7c1aRU-21 HANGOVER RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73156-010-20RU-21 HANGOVER RELIEF1 in 1 BOXCAPSULE11
73156-010-20RU-21 HANGOVER RELIEF20 in 1 BLISTER PACKCAPSULE201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73156-010RU-21 HANGOVER RELIEF (ASPIRIN, CAFFEINE) CAPSULE [RU-21]1Legacy NDC, 2 package rows20190701_ebba9ac5-39f2-44ba-a391-44d8fce7f70b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73156-01073156-010-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8bda2451-a064-de63-e053-2a95a90aa1cfebba9ac5-39f2-44ba-a391-44d8fce7f70b2019-06-21WarningsExact identifier
spl id: 8bda2451-a064-de63-e053-2a95a90aa1cf
spl set id: ebba9ac5-39f2-44ba-a391-44d8fce7f70b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.