REVASOL NIGHTTIME COLD AND FLU

Manufacturer
Rnv LLC
Effective date
2025-03-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:42

Label at a glance#

ProductREVASOL NIGHTTIME COLD AND FLU
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 30 mL dose cup) Purpose
Acetaminophen 650 mg................................................Pain Reliever-Fever Reducer
Dextromethorphan HBr 30 mg......................................Cough Suppressant
Doxylamine Succinate 12.5mg......................................Antihistamine

OTC - PURPOSE SECTION

Pain Reliever-Fever Reducer

Cough Suppressant

Antihistamine

INDICATIONS & USAGE SECTION

Uses

• temporarily relieves common cold/flu symptoms: • sore throat • minor aches and
pains • runny nose and sneezing • headache • fever • cough due to minor throat and
bronchial irritation.

WARNINGS SECTION

Warnings

Liver warning This product contains acetaminophen. Severe liver damage may occur if:
• adults and children over 12 years of age take more than 4 doses (30 mL each in 24 hours,
which is the maximum daily amount for this product
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: •
skin reddening • blisters • rash. If a skin reaction occurs, stop use and seek medical help
right away.
Sore throat warning: If sore throat is severe, lasts for mroe than 2 days, is accompanied
or followed by fever, heacache, rash, nausea, or vomiting, consult a doctor promptly.

OTC - DO NOT USE SECTION

Do not use

• with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor
or pharmacist. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI)
(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease),
or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug
contains an MAOI, ask a doctor or pharmacist before taking this product. • to make a child
sleepy

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have • liver disease • glaucoma • cough that occurs with
too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occur
with smoking, asthma, chronic bronchitis or emphysema • trouble urinating due to an
enlarged prostate gland.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

When using this product • do not use more than directed • avoid alcoholic drinks • excitability may occur, especially in children • marked drowsiness may occur • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness.

OTC - STOP USE SECTION

Stop use and ask a doctor if

• pain or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If pregnant or breast-feeding, ask a health professional before use.

OVERDOSAGE SECTION

Overdose warning:

Taking mroe than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

• take only as directed (see overdose warning)
• measure only with dosing cup provided and keep dosage cup with product
• mL=mililiter • do not exceed 4 doses per 24 hours

AgeDose
adults and children 12 years of and over30 mL every 6 hours
children under 12 yearsdo not use

• when using Day Time and Night Time products, limit total to 4 doses per 24 hours

OTHER SAFETY INFORMATION

Other Information

• Each 30 mL dose cup contains: sodium 10 mg
• store at room temperature 15-30°C (59-86°F) and do not refrigerate
TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing.

INACTIVE INGREDIENT SECTION

Inactive ingredients citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

OTC - QUESTIONS SECTION

Questions or comments 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REVASOL NIGHTTIME.JPGREVASOL NIGHTTIME.JPG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN1
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD1
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY1
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY1
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84379-276-04REVASOL NIGHTTIME COLD AND FLU118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84379-276REVASOL NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) LIQUID [RNV LLC]1Current NDC, 1 package rows20250326_30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84379-27684379-276-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
REVASOL NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATERnv LLC30dfd8f7-4cc6-d4f2-e063-6394a90aa9c92025-03-21WarningsExact identifier
ndc (package): 84379-276-04
ndc (product): 84379-276
ndc11 (package): 84379027604
spl id: 30dfd8f7-4cc7-d4f2-e063-6394a90aa9c9
spl set id: 30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9

Reported adverse events (FAERS/openFDA)#

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