Daytime Nighttime Cold and Flu Relief

Manufacturer
Spirit Pharmaceuticals LLC | MEDGEL PRIVATE LTD
Effective date
2020-03-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:39:27

Label at a glance#

ProductDaytime Nighttime Cold and Flu Relief Multi-Symptom
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

DAYTIME temporarily relieves common cold and flu symptoms cough due to minor throat and bronchial irritation nasal congestion headache minor aches and pains fever sore throat NIGHTTIME temporarily relieves common cold and fly symptoms cough due to minor throat and bronchial irritation sore throat headache minor aches and pain fever runny nose and sneezing

Dosage and administration

DAYTIME do not take more than directed (see Overdose warning  ) do not take more than 4 doses in 24 hours  adults and children 12 years and over: take 2 softgels with water every 4 hours children 4 to under 12 years of age: ask a doctor children under 4 years of age : do not use Nighttime: do not take more than directed (see Overdose warning) do not take more than 4 doses in 24 hours adults and children 12 years a...

Storage and handling

DAYTIME and NIGHTTIME store between 15-30°C (59-86°F) avoid excessive heat

Label contents#

Full prescribing information#

Active ingredients in Daytime (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients in Nighttime (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose for Daytime

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Nighttime

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

DAYTIME

  • temporarily relieves common cold and flu symptoms
    • cough due to minor throat and bronchial irritation
    • nasal congestion
    • headache
    • minor aches and pains
    • fever
    • sore throat

NIGHTTIME

  • temporarily relieves common cold and fly symptoms
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pain
    • fever
    • runny nose and sneezing

Warnings

WARNINGS SECTION

DAYTIME and NIGHTTIME

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

  • more than 4 doses 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, 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

DAYTIME and NIGHTTIME

  • 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

DAYTIME

  • liver disease
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • 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, or emphysema

NIGHTTIME

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

DAYTIME

  • taking the blood thinning drug warfarin

NIGHTTIME

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

When using this product,

OTC - WHEN USING SECTION

DAYTIME

do not exceed recommended dosage.

NIGHTTIME

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

DAYTIME

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

NIGHTTIME

  • 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.

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

DAYTIME and NIGHTTIME

Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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

DAYTIME

  • do not take more than directed (see Overdose warning )
  • do not take more than 4 doses in 24 hours 
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • children 4 to under 12 years of age: ask a doctor
  • children under 4 years of age : do not use

Nighttime:

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 6 hours
  • children 4 to under 12 years of age: ask a doctor
  • children under 4 years of age : do not use

Other information

STORAGE AND HANDLING SECTION

DAYTIME and NIGHTTIME

  • store between 15-30°C (59-86°F)
  • avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Daytime FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide  

Nighttime D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENTS IN VICKS® DAYQUIL® & VICKS® NYQUIL® LIQUICAPS® Cold &Flu LiquiCaps®**

MULTI-SYMPTOM

Daytime Liquid Capsules

Acetaminophen - Pain Reliever / Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Phenylephrine HCl - Nasal Decongestant

Fever, Headache, Sore Throat, Coughing, Minor Aches and Pains, & Nasal Congestion

Non-drowsy, Alcohol-free antihistamine-free

SOFTGELS

MULTI-SYMPTOM

Nite Time

Liquid Capsules

Acetaminophen - Pain Reliever / Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Doxylamine Succinate - Antihistamine

Fever, Headache, Sore Throat, Coughing, Minor Aches and Pains, Runny Nose & Snezzing

Alcohol-free

softgels

**This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil®, NyQuil®, and LiquiCap® are registered trademarks of The Procter and Gamble Company.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-040568210-0405-2

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ee01beea-e915-5bdb-e053-2995a90a1dce276ea7ac-8dfb-481d-9bc1-fd67018dd5dc2022-11-21WarningsExact identifier
spl set id: 276ea7ac-8dfb-481d-9bc1-fd67018dd5dc

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