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Daytime Cold and Flu

Meijer Distribution, Inc. DayTime Cold & Flu Drug Facts

Approved
Approval ID

932b11b1-f4a0-417a-bfa1-05261a172155

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

Meijer Distribution Inc

DUNS: 006959555

Products 1

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

acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41250-603
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (16)

ACETAMINOPHENActive
Quantity: 325 mg in 15 mL
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 15 mL
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 200 mg in 15 mL
Code: 495W7451VQ
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 15 mL
Code: 04JA59TNSJ
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

Package/Label Principal Display Panel

meijer®

MAXIMUM STRENGTH

NON-DROWSY

DayTime Cold & Flu

Acetaminophen (Pain Reliever/Fever Reducer)

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

Phenylephrine HCl (Nasal Decongestant)

COMPARE TO VICKS® DAYQUIL® SEVERE COLD & FLU ACTIVE INGREDIENTS

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

SEVERE COLD & FLU

Alcohol Free

Antihistamine Free

Multi-Symptom Relief

12 FL OZ (355 mL)

meijer-daytime-cold-&-flu-container- image.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/28/2024

Uses

temporarily relieves common cold/flu symptoms:

sinus congestion and pressure

nasal congestion

minor aches and pains

headache

sore throat

fever

cough due to minor throat and bronchial irritation

reduces swelling of nasal passages

promotes nasal and/or sinus drainage

temporarily restores freer breathing through the nose

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/19/2015

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/2/2014

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 9/19/2025

Warnings

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

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

liver disease

heart disease

high blood pressure

thyroid disease

diabetes

cough that occurs with too much phlegm (mucus)

trouble urinating due to an enlarged prostate gland

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if

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,

ask a health professional before use.

Keep out of reach of children.

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/19/2025

Directions

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 SECTION

LOINC: 44425-7Updated: 9/19/2025

Other information

**each 15 mL contains:** sodium 6 mg

store at 20-25°C (68-77°F). Do not refrigerate.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/28/2024

Inactive ingredients

butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/19/2025

Questions?

1-800-719-9260

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Daytime Cold and Flu - FDA Drug Approval Details