REVASOL DAYTIME COLD AND FLU
- Manufacturer
- Rnv LLC
- Effective date
- 2025-03-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:56:58
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 650mg....................................................Pain reliever-Fever reducer
Dextromethorphan HBr 20 mg.........................................Cough suppressant
Phenylephrine HCl 10 mg................................................Nasal decongestant
OTC - PURPOSE SECTION
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
• temporarily relieves common cold/flu symptoms: • minor aches and pains
• headache • sore throat • fever • nasal congestion • 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 more than 2 days, is accompanied
or followed by fever, headache, 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. • if you have ever
had an allergic reaction to this product or any of its ingredients.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
• liver disease • heart disease • high blood pressure
• diabetes • thyroid disease • trouble urinating due to an enlarged prostate gland • a cough
that occurs with too much phlegm (mucus) or a persistent or chronic cough such as occurs
with smoking, asthma, or emphysema
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 (see overdose warning)
• avoid alcoholic drinks.
OTC - STOP USE SECTION
Stop use and ask a doctor if
• you get nervous, dizzy or sleepless • pain, nasal
congestion or cough get worse or lasts more than 5 days (children) or 7 days (adults)
• 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 more 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 4 hours |
| children under 12 years | do not use |
- when using Day Time and Night Time products, carefully read each label to ensure correct dosing.
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 Yellow #6, 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 |
|---|---|---|---|
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 1 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 1 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 1 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 1 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84379-275-04 | REVASOL DAYTIME 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 DAYTIME COLD AND FLU
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- WATER
- XANTHAN GUM
- GLYCERIN
- SODIUM BENZOATE
- PROPYLENE GLYCOL
- CITRIC ACID
- SORBITOL SOLUTION
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACETAMINOPHEN
- SUCRALOSE
- MENTHOL
- FD&C YELLOW NO. 6
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84379-275 | 84379-275-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| WATER | 059QF0KO0R | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CITRIC ACID | 2968PHW8QP | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | 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 DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Rnv LLC | 2f9ddcc3-b913-f8b0-e063-6294a90a93ab | 2025-03-05 | Warnings | 84379-275-04 84379-275 84379027504 2f9ddcc3-b914-f8b0-e063-6294a90a93ab 2f9ddcc3-b913-f8b0-e063-6294a90a93ab |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
