FDA.reportPublic FDA data

Daytime cold and flu

Manufacturer
Meijer Distribution Inc
Effective date
2026-01-23
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:34:52

Label at a glance#

ProductDaytime cold and flu non drowsy
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • nasal congestion • minor aches and pains • sore throat • headache • fever

Dosage and administration

• take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

Storage and handling

• each 15 mL contains: sodium 15 mg • store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

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

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • 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 any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough gets worse or lasts 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed – see Overdose warning
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 6 to under 12 yrs

15 mL every 4 hrs

children 4 to under 6 yrs

ask a doctor

children under 4 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 15 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C yellow no. 6, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

meijer®

MAXIMUM STRENGTH

NON-DROWSY

DayTime Cold & Flu

Acetaminophen (Pain Reliever / Fever Reducer)

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

COMPARE TO VICKS® DAYQUIL® COLD & FLU ACTIVE INGREDIENTS

RELIEVES: ACHES, PAIN, FEVER, COUGH, NASAL CONGESTION, SORE THROAT

Alcohol Free

Antihistamine Free

Multi-Symptom Relief

12 FL OZ (355 mL)

C:\Users\sbrown\OneDrive - Perrigo\My Docs\Pictures\656-6e-daytime-cold-and-flu.jpg
C:\Users\sbrown\OneDrive - Perrigo\My Docs\Pictures\656-6e-daytime-cold-and-flu.jpg

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 SolutionPSN10
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD10
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY10
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY10
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSY10

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
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-656-38Daytime cold and flunon drowsy296 mL in 1 BOTTLESOLUTION29610
41250-656-40Daytime cold and flunon drowsy355 mL in 1 BOTTLESOLUTION35510

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D4
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ4
ACETAMINOPHENACTIVE MOIETY362O9ITL9D4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2U4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A84
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
MENTHOLINACTIVE INGREDIENTL7T10EIP3A4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY4
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SW4
SUCROSEINACTIVE INGREDIENTC151H8M5544
WATERINACTIVE INGREDIENT059QF0KO0R4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE4

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-65641250-656-38, 41250-656-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL SOLUTION8KW3E207O2IACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2USOLUTION / ORAL5 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSOLUTION / ORAL25 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2USOLUTION / ORAL5 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSOLUTION / ORAL25 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSOLUTION / ORAL25 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2USOLUTION / ORAL5 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
daytime nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc80aae1c3-a616-442b-842e-177db957a69c2026-08-04WarningsExact identifier
ndc (package): 41250-656-40
ndc11 (package): 41250065640
Daytime cold and flu non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMeijer Distribution Inc29caa3a7-7fe6-4134-a9b0-49bdb9280ca72026-01-23WarningsExact identifier
ndc (package): 41250-656-38
ndc (package): 41250-656-40
ndc (product): 41250-656
ndc11 (package): 41250065638
ndc11 (package): 41250065640
spl id: ca0850da-738b-488b-9782-80c8dec7e9bb
spl set id: 29caa3a7-7fe6-4134-a9b0-49bdb9280ca7

Reported adverse events (FAERS/openFDA)#

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