MedPath

DAYTIME COLD AND FLU

DAYTTIME COLD & FLU

Approved
Approval ID

0609120e-c348-494e-b4a0-863e77d7963a

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, dextromethorphan HBr, Phenylephrine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code37835-527
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
acetaminophen, dextromethorphan HBr, Phenylephrine HCl
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (13)

CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 15 mL
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 15 mL
Code: 9D2RTI9KYH
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 15 mL
Code: 04JA59TNSJ
Classification: ACTIM

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 and flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • fever
  • nasal congestion
  • cough due to minor throat and bronchial irritation

OTC - STOP USE SECTION

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

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough get worse or last 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 - ASK DOCTOR/PHARMACIST SECTION

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

Ask a doctor or pharmacist before use if you are

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

OTC - ACTIVE INGREDIENT SECTION

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

Drug Facts

Active ingredients (in each 15 mL dose cup)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

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

Purpose

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

WARNINGS SECTION

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

Warnings

**Liver warning:**This product contains acetaminophen. Sever 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
  • children 6 to 12 years of age take more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
  • take with other drug containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

**Allergy alert:**Acetaminophen may cause sever skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • ras

If skin reaction occurs, stop use and seek medical help right away.

**Sore throat warning:**If sore throat is sever, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other products 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 diseas), or for 2 weeks after stopping the MAOI drugs. 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 o its ingredients

OTC - ASK DOCTOR SECTION

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

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • diabete
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • cough accompanied by excessive phlegm (mucus)
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

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 more than the recommended dose (overdose) may cause serious health problemas including liver damamge. 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 ou 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 dose cup provided and keep dose cup with product
  • mL=mililiter
  • do not exceed 4 doses per 24 hours

Age

Dose

adults & children 12 years and over

30 mL every 4 hours

children 6 to under 12 years

15 mL every 4 hours

children under 6 years

do not use

OTHER SAFETY INFORMATION

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

Other information

***each 15 mL contains:**sodium 5 mg

  • store at room temperature 15-30°C (59-86°C) and do not refrigerate

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Keep out of reach of children.

INACTIVE INGREDIENT SECTION

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

Inactive ingredients

Citric acid, FD&C Yellow No 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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DAYTIME COLD AND FLU - FDA Drug Approval Details