health mart day time cold and flu night time cold and flu

Manufacturer
Strategic Sourcing Services LLC
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:46:42

Label at a glance#

Producthealth mart day time cold and flu night time cold and flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure25 sections

Indications and uses

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

Dosage and administration

• take only as directed – see overdose warning • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Storage and handling

• store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredients (in each softgel) – Nighttime Cold & Flu

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredients (in each softgel) – Daytime Cold & Flu

SPL UNCLASSIFIED SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose – Nighttime Cold & Flu

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose – Daytime Cold & Flu

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses – Nighttime Cold & Flu

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Uses – Daytime Cold & Flu

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

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

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:

  • 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, lasts 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 – Nighttime Cold & Flu

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • trouble urinating due to an enlarged prostate gland

Ask a doctor before use if you have – Daytime Cold & Flu

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 as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are – Nighttime Cold & Flu

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product – Nighttime Cold & Flu

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

When using the product – Daytime Cold & Flu

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if – Nighttime Cold & Flu

OTC - STOP USE SECTION

  • pain 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.

Stop use and ask a doctor if – Daytime Cold & Flu

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • 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

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 – Nighttime Cold & Flu

DOSAGE & ADMINISTRATION SECTION

  • take only as directed – see overdose warning
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Directions – Daytime Cold & Flu

DOSAGE & ADMINISTRATION SECTION

  • take only as directed – see overdose warning
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients – Nighttime Cold & Flu

INACTIVE INGREDIENT SECTION

D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Inactive ingredients – Daytime Cold & Flu

INACTIVE INGREDIENT SECTION

edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Vicks® DayQuil® Cold & Flu active ingredients

DAYTIME RELIEF

DayTime Cold & Flu

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant

For Relief of:

Aches/Fever/Sore Throat

Nasal Congestion – Cough

Alcohol Free

Antihistamine Free

Gluten Free

Actual Size

32 Softgels

Compare to Vicks® NyQuil® Cold & Flu active ingredients

NIGHTIME RELIEF

NightTime Cold & Flu

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine

For Relief of:

Aches/Fever/Sore Throat

Sneezing/Runny Nose – Cough

Alcohol Free

Gluten Free

Actual Size

16 Softgels

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day time night time cold and flu image 1
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day time night time cold and flu image 2

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62011-043762011-0437-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Source Document#

Source XML

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
f4c3bf47-fbd4-490b-9d4a-2ec8c71172d7c6d22c2d-e5f0-429d-870b-684bf5f8b8e92024-12-10WarningsExact identifier
spl id: f4c3bf47-fbd4-490b-9d4a-2ec8c71172d7
spl set id: c6d22c2d-e5f0-429d-870b-684bf5f8b8e9

Reported adverse events (FAERS/openFDA)#

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