REVASOL DAYTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

REVASOL DAYTIME COLD AND FLU by

Drug Labeling and Warnings

REVASOL DAYTIME COLD AND FLU by is a Otc medication manufactured, distributed, or labeled by Rnv LLC, RNV LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

INDICATIONS & USAGE

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

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.

DO NOT USE

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.

ASK DOCTOR

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

ASK DOCTOR/PHARMACIST

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

WHEN USING

When using this product

do not use more than directed (see overdose warning)
avoid alcoholic drinks.

STOP USE

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.

KEEP OUT OF REACH OF CHILDREN

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

OVERDOSAGE

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

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

Inactive ingredients

citric acid, FD&C Yellow #6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REVASOL DAYTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84379-275
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 30 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID (UNII: 2968PHW8QP)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MENTHOL (UNII: L7T10EIP3A)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84379-275-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/03/2025

Labeler - Rnv LLC (118917568)

Registrant - Rnv LLC (118917568)

Establishment
Name	Address	ID/FEI	Business Operations
RNV LLC		118917568	manufacture(84379-275)