FDA.reportPublic FDA data

Severe Cold and Flu

Manufacturer
Wal-Mart Stores Inc | LNK International, Inc.
Effective date
2024-08-24
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 20:48:37

Label at a glance#

ProductSevere Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: cough sore throat headache minor aches and pains nasal congestion runny nose and sneezing (Nighttime only) temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only) controls cough to help you get to sleep (Nighttime only)

Dosage and administration

do not take more than directed do not take more than 6 doses in any 24-hour period mL = milliliter; FL OZ = fluid ounce use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: do not use

Storage and handling

each 20 mL contains: sodium 10 mg (Daytime only) , sodium 9 mg (Nighttime only) store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL) (Daytime)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Active ingredients (in each 20 mL) (Nighttime)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • sore throat
    • headache
    • minor aches and pains
    • nasal congestion
    • runny nose and sneezing (Nighttime only)
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
  • controls cough to help you get to sleep (Nighttime only)

Warnings

WARNINGS SECTION

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

  • with other drugs containing acetaminophen
  • more than 4,000 mg of acetaminophen in 24 hours
  • 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

  • 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.
  • 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 have ever had an allergic reaction to this product or any of its ingredients
  • with any other product containing diphenhydramine, even one used on skin (Nighttime only)

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)

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 accidental 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.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • do not take more than 6 doses in any 24-hour period
  • mL = milliliter; FL OZ = fluid ounce
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each 20 mL contains: sodium 10 mg (Daytime only), sodium 9 mg (Nighttime only)
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients (Daytime only)

INACTIVE INGREDIENT SECTION

anhydrous citric acid, disodium edetate, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

Inactive ingredients (Nighttime only)

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-888-287-1915

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

equate™

Compare
to Maximum
Strength Mucinex®
FAST-MAX® Day Time
Severe Cold and
Night Time Cold & Flu
Active
Ingredients†

NDC 49035-945-02

Maximum Strength

Daytime
Severe Cold

Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant

Multi-Symptom Relief

• Relieves aches, fever & sore throat
• Controls cough
• Relieves nasal & chest congestion
• Thins & loosens mucus

Ages 12+

Maximum Strength

Nighttime
Cold & Flu

Acetaminophen - Pain Reliever/Fever Reducer
Diphenhydramine HCl - Antihistamine/
Cough Suppressant
Phenylephrine HCl - Nasal Decongestant

Multi-Symptom Relief

• Relieves aches, fever & sore throat
• Controls cough
• Relieves nasal congestion
• Relieves runny nose & sneezing

Ages 12+

 TWO - 6 FL OZ (177 mL) BOTTLES       TOTAL - 12 FL OZ (355 mL)

TAMPER EVIDENT: DO NOT
USE IF IMPRINTED
SAFETY SEAL UNDER CAP
IS BROKEN OR MISSING

PARENTS:
Learn about teen medicine abuse:
www.StopMedicineAbuse.org

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

†This product is not manufactured or distributed by Reckitt Benckiser LLC, owner
of the registered trademark Maximum Strength Mucinex® FAST-MAX® Day Time
Severe Cold and Night Time Cold & Flu.
50844         REV0218C04201145                                        W-2203-042011-45SS

Satisfaction guaranteed – Or we’ll replace it or
give you your money back. For questions or
comments or to report an undesired reaction
or side effect, please call 1-888-287-1915.

Equate 44-042011Equate 44-042011

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-94549035-945-02
49035-84249035-842-45
49035-81149035-811-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SODIUM METABISULFITE4VON5FNS3CIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SODIUM METABISULFITE4VON5FNS3CIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML · Source PDF

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
6179ebcf-2c1e-4360-b82c-13494cf6aad02f2f6439-4124-4fb9-9562-42f2edf4e1ea2024-08-24WarningsExact identifier
spl id: 6179ebcf-2c1e-4360-b82c-13494cf6aad0
spl set id: 2f2f6439-4124-4fb9-9562-42f2edf4e1ea

Reported adverse events (FAERS/openFDA)#

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