DAYTIME NIGHTTIME COLD FLU RELIEF

Manufacturer
APNAR PHARMA LP | APNAR PHARMA LLP
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:23:36

Label at a glance#

ProductDAYTIME NIGHTTIME COLD FLU RELIEF
Active ingredientACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure13 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients for Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

OTC - ACTIVE INGREDIENT SECTION

Active ingredients for Nighttime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

OTC - PURPOSE SECTION

Purposes

for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

OTC - PURPOSE SECTION

Purposes

for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

INDICATIONS & USAGE SECTION

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

Uses

Nighttime

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

WARNINGS SECTION

Warnings

Daytime

Liver warning: These products contain 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 products

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.

Nighttime

Liver warning: These products contain 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 products

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

Daytime

  • 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.

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

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 such as occurs 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

Daytime

taking the blood thinning drug warfarin

Nighttime

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

When using this product

Daytime

do not exceed recommended dosage

Nighttime

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

Daytime

  • nervousness, dizziness or sleeplessness occur
  • pain, cough, and nasal congestion gets worse or lasts more than 7 days
  • redness or swelling is present
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • 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 headache that lasts.

These could be a signs of a serious condition

If pregnant or breast-feeding,

ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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 (1-800-222- 1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

Daytime

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • swallow whole; do not crush, chew, or dissolve

adults and children 12 years and over: take 2 softgels with water every 4 hours.

children under 12 years: do not use

Nighttime

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • swallow whole; do not crush, chew, or dissolve

adults and children 12 years and over: take 2 softgels with water every 6 hours

children under 12 years: do not use

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

Daytime

Gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, FD&C yellow #6, FD&C Red #40 , white ink

Nighttime

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

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-855-642-2594

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the active ingredients in Vicks® DayQuil® and NyQuil® Cold & Flu LiquiCaps®

Daytime

NDC 24689-152-01

Multi-Symptom Cold & Flu Relief

Acetaminophen 325 mg- Pain reliever / Fever reducer

Dextromethorphan HBr 10 mg - Cough suppressant

Phenylephrine HCI 5 mg - Nasal decongestant

Relieves:

  • Aches, fever, sore throat
  • Cough
  • Nasal congestion

Non-drowsy

Alcohol-Free

Antihistamine-Free

Softgels**

(** Liquid-filled capsules)

Nighttime

Multi-Symptom Cold & Flu Relief

Acetaminophen 325 mg - Pain reliever / Fever reducer

Dextromethorphan HBr 15 mg - Cough suppressant

Doxylamine succinate 6.25 mg - Antihistamine

Relieves:

  • Aches, fever, sore throat
  • Cough
  • Runny nose, sneezing

Softgels**

Alcohol-free

(**Liquid-filled capsules)

When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing.

†This product is not manufactured or distributed by The Procter & Gamble Company.

Vicks®, DayQuil®, NyQuil®, and LiquiCaps® are registered trademarks of the Procter and Gamble Company.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:

APNAR PHARMA LP

CHINO, CA, USA, 91710

Rev.: 04/2023

Daytime and Nighttime Soft Gel-Carton-labelDaytime and Nighttime Soft Gel-Carton-label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-152DAYTIME NIGHTTIME COLD FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [APNAR PHARMA LP]2Unmatched20231022_f3d9d25b-486d-c693-e053-2a95a90a533b.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24689-15224689-152-01
24689-157
24689-158

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
c577a954-c140-4b46-a13f-26fb5cd72201f3d9d25b-486d-c693-e053-2a95a90a533b2025-07-01WarningsExact identifier
spl set id: f3d9d25b-486d-c693-e053-2a95a90a533b

Reported adverse events (FAERS/openFDA)#

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