FDA.reportPublic FDA data

Meijer 44-617 CF

Manufacturer
Meijer Distribution, Inc. | LNK International, Inc.
Effective date
2026-08-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-08-29 01:02:16

Label at a glance#

ProductCold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: sinus congestion and pressure headache sore throat nasal congestion cough minor aches and pains temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

do not take more than directed do not take more than 12 caplets in any 24-hour period adults and children 12 years and over: take 2 caplets every 4 hours children under 12 years: do not use

Storage and handling

each caplet contains: sodium 3 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg 
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg 

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
    • sinus congestion and pressure
    • headache
    • sore throat
    • nasal congestion
    • cough
    • minor aches and pains
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

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
  • diabetes
  • thyroid disease
  • heart disease
  • high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland

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 exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, 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.

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

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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

  • do not take more than directed
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years and over: take 2 caplets every 4 hours
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: sodium 3 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

meijer®

NDC 79481-6170-9

Compare to Maximum
Strength Mucinex® Fast-Max®
Cold & Flu active ingredients*

Cold & Flu

Acetaminophen
Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl

Pain Reliever/Fever Reducer
Cough Suppressant
Expectorant
Nasal Decongestant

Maximum Strength / Multi-Symptom

Relieves:
Headache, Body Pain
Sore Throat, Fever, Cough
Nasal & Chest Congestion
Sinus Congestion & Pressure

Actual Size

20
CAPLETS

Meijer 44-617
Meijer 44-617

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130719283788290GTIN-13: 0719283788290
EAN-13: 0719283788290
GTIN-12: 719283788290
UPC-A: 719283788290
GTIN storage (14 digits): 00719283788290		meijer-44-617-cf-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79481-617079481-6170-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-10-28full-release2026-06-01 01:41:32
22024-10-29full-release2026-06-01 00:31:47

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
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
ndc (package): 79481-6170-9
ndc (product): 79481-6170
ndc11 (package): 79481617009
spl id: a621e2d9-b4ec-496a-a786-8849f2ff3112
spl set id: c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d

Reported adverse events (FAERS/openFDA)#

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