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#
Contacts and useful links#
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
| Age | Dose |
| adults and children 12 years of and over | 30 mL every 6 hours |
| children under 12 years | do 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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 1 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 1 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 1 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 1 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84379-276-04 | REVASOL NIGHTTIME COLD AND FLU | 118 mL in 1 BOTTLE | LIQUID | 118 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- REVASOL NIGHTTIME COLD AND FLU
- Acetaminophen, Dextromethorphan HBr and Doxylamine succinate
- PROPYLENE GLYCOL
- ACETAMINOPHEN
- SODIUM BENZOATE
- XANTHAN GUM
- GLYCERIN
- FD&C BLUE NO. 1
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- WATER
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- FD&C RED NO. 40
- SUCRALOSE
- MENTHOL
- ANHYDROUS CITRIC ACID
- SORBITOL SOLUTION 70%
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84379-276 | 84379-276-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| WATER | 059QF0KO0R | IACT |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SORBITOL SOLUTION 70% | 8KW3E207O2 | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| REVASOL NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Rnv LLC | 30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9 | 2025-03-21 | Warnings | 84379-276-04 84379-276 84379027604 30dfd8f7-4cc7-d4f2-e063-6394a90aa9c9 30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
