REVASOL NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr and doxylamine succinate liquid

REVASOL NIGHTTIME COLD AND FLU by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Pain Reliever-Fever Reducer

Cough Suppressant

Antihistamine

INDICATIONS & USAGE

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

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.

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. to make a child
sleepy

ASK DOCTOR

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.

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 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.

STOP USE

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.

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 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

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

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.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REVASOL NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr and doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84379-276
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MENTHOL (UNII: L7T10EIP3A)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84379-276-04	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(84379-276)