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NIGHTTIME COLD AND FLU

NIGHTTIME COLD & FLU

Approved
Approval ID

36aa5df7-8722-4b80-aa04-d869bc944311

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 1, 2025

Manufacturers
FDA

BI-MART

DUNS: 027630078

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen, Doxylamine succinate and Dextromethorphan HBr

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code37835-525
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Doxylamine succinate and Dextromethorphan HBr
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (15)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SORBITOL SOLUTION 70%Inactive
Code: 8KW3E207O2
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ACETAMINOPHENActive
Quantity: 650 mg in 30 mL
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 30 mg in 30 mL
Code: 9D2RTI9KYH
Classification: ACTIB
DOXYLAMINE SUCCINATEActive
Quantity: 12.5 mg in 30 mL
Code: V9BI9B5YI2
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/20/2025

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/20/2025

Keep out of the reach of children.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/20/2025

Drug Facts

Active ingredients (in each 30 mL dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/20/2025

Purpose

Pain Reliever/Fever Reducer

Cough Suppressant

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 5/20/2025

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

LOINC: 50570-1Updated: 5/20/2025

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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/20/2025

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

LOINC: 50568-5Updated: 5/20/2025

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/20/2025

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.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/20/2025

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 - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/20/2025

If pregnant or breast-feeding,

ask a health professional before use.

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 5/20/2025

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/20/2025

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 SAFETY INFORMATION

LOINC: 60561-8Updated: 5/20/2025

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 5/20/2025

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.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/20/2025

Questions or comments?

1-844-912-4012

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NIGHTTIME COLD AND FLU - FDA Drug Approval Details