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

NIGHTTIME COLD AND FLU by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredients (in each 30 mL dose cup) 

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Purpose

Pain Reliever/Fever Reducer

Cough Suppressant

Antihistamine

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

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

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 anay of its ingredients

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 a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin.

When using this product

  do not use more than directed (see overdose warning)

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 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.

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

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 (1-800-222-1222) immediately.Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 and over: 30 mL every 6 hours
• children under 12 years: do not use

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

Inactive ingredients

citric acid, D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

Questions or comments?

1-844-912-4012

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-525
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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
WATER (UNII: 059QF0KO0R)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MENTHOL (UNII: L7T10EIP3A)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-525-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/01/2025

Labeler - BI-MART (027630078)

Registrant - BI-MART (027630078)

Establishment
Name	Address	ID/FEI	Business Operations
Rnv LLC		118917568	manufacture(37835-525)