DAYTIME COLD AND FLU

Manufacturer
BI-MART | Rnv LLC
Effective date
2025-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:20

Label at a glance#

ProductDAYTIME COLD AND FLU
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and 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

Dosage and administration

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 

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 15 mL dose cup)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning:

OVERDOSAGE SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
AgeDose
adults & children 12 years and over30 mL every 4 hours
 children 6 to under 12 years15 mL every 4 hours
 children under 6 yearsdo not use 

Other information

OTHER SAFETY INFORMATION

  • each 15 mL contains:sodium 5 mg
  • store at room temperature 15-30°C (59-86°C) and do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, FD&C Yellow No 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or Comments?

OTC - QUESTIONS SECTION

1-844-912-4012

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN1
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD1
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY1
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY1
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37835-527-12DAYTIME COLD AND FLU355 mL in 1 BOTTLELIQUID3551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37835-527DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BI-MART]11 package rows20250523_0609120e-c348-494e-b4a0-863e77d7963a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37835-52737835-527-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
35915a1f-2ecb-edc8-e063-6394a90ab97f0609120e-c348-494e-b4a0-863e77d7963a2025-05-01WarningsExact identifier
spl id: 35915a1f-2ecb-edc8-e063-6394a90ab97f
spl set id: 0609120e-c348-494e-b4a0-863e77d7963a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.