Severe Cough and Congestion and Cold and Flu

Manufacturer
Meijer Distribution Inc | LNK International, Inc.
Effective date
2025-09-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:34:44

Label at a glance#

ProductSevere Cough and Congestion and Cold and Flu Daytime, Nighttime
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants nasal congestion due to a cold the intensity of coughing the impulse to cough to help you get to sleep 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 use 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  (Daytime only) 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) use by expiration date on package

Label contents#

Full prescribing information#

Active ingredients (in each caplet) (Daytime Severe Congestion & Cough)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant
Nasal decongestant

Active ingredients (in each caplet) (Nighttime Cold & Flu)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant

Uses (Daytime only)

INDICATIONS & USAGE SECTION

  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • nasal congestion due to a cold
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Uses (Nighttime only)

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
    • headache
    • sore throat
    • nasal congestion
    • runny nose and sneezing
    • cough
    • minor aches and pains
  • temporarily reduces fever
  • controls cough to help you get to sleep

Warnings

WARNINGS SECTION

Liver warning (Nighttime only): 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 (Nighttime only): 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 (Nighttime only): 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 product containing diphenhydramine, even one used on skin (Nighttime only)
  • 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. (Nighttime only)
  • 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

  • heart disease
  • diabetes
  • thyroid disease
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • high blood pressure
  • 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)
  • liver disease (Nighttime only)

Ask a doctor or pharmacist before use if you are (Nighttime only)

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever (Daytime only)
  • redness or swelling is present (Nighttime only)
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days (Nighttime only)
  • new symptoms occur (Nighttime only)
  • fever gets worse or lasts more than 3 days (Nighttime only)
  • 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.

Do not take DAYTIME and NIGHTTIME products at the same time.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use 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 (Daytime only)
  • 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)
  • use by expiration date on package

Inactive ingredients (Daytime only)

INACTIVE INGREDIENT SECTION

corn starch, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive ingredients (Nighttime only)

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMBO PACK
30 CAPLETS TOTAL

NDC 41250-848-95

Meijer®

Maximum Strength
Daytime Severe
Congestion & Cough

Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Cough Suppressant
Expectorant
Nasal Decongestant

• Controls Cough
• Relieves Nasal &
  Chest Congestion
• Thins & Loosens Mucus

20
Caplets
Actual Size 

Maximum Strength
Nighttime Cold & Flu

 Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

Pain Reliever/Fever Reducer
Antihistamine/Cough Suppressant
Nasal Decongestant

• Relieves Aches,
  Fever & Sore Throat
• Relieves Nasal Congestion,
  Runny nose & Sneezing
• Controls Cough

10
Caplets
Actual Size 

50844 ORG052364869401

Do Not Take Daytime and
Nighttime Products at the
Same Time

DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com

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

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF
BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING

Meijer 44-648694Meijer 44-648694

 

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-84841250-848-95
41250-59141250-591-03
41250-59241250-592-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
86cc6869-df19-415a-adb5-0bc326b7851532ce39a6-2eb6-4792-ba94-580175f493852025-09-02WarningsExact identifier
spl id: 86cc6869-df19-415a-adb5-0bc326b78515
spl set id: 32ce39a6-2eb6-4792-ba94-580175f49385

Reported adverse events (FAERS/openFDA)#

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