COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2020-12-07
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:03:44

Label at a glance#

ProductCOLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure30 sections

Indications and uses

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

Dosage and administration

take only as directed – see Overdose warning do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 capsules with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

Drug Facts - Day Time

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each capsule)

Acetaminophen USP 325 mg
Dextromethorphan HBr USP 10 mg
Phenylephrine HCl USP 5 mg

Drug Facts - Night Time

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each capsule)

Acetaminophen USP 325 mg
Dextromethorphan HBr USP 15 mg
Doxylamine succinate USP 6.25 mg

Purpose - Day Time

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Purpose - Night Time

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Antihistamine



Uses - Day Time

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

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

Uses - Night Time

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

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

Warnings - Day Time

WARNINGS SECTION

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

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Warnings - Night Time

WARNINGS SECTION

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

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Do not use - Day Time

SPL UNCLASSIFIED 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.

Do not use - Night Time

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.
  • to make a child sleep

Ask a doctor before use if you have - Day Time

SPL UNCLASSIFIED SECTION


  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to 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 before use if you have - Night Time

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are - Day Time

SPL UNCLASSIFIED SECTION

taking the blood thinning drug warfarin.

Ask a doctor or pharmacist before use if you are - Night Time

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product,

SPL UNCLASSIFIED SECTION

do not use more than directed.

When using this product - Night Time

OTC - WHEN USING SECTION

  • do not use more than directed
  • 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, & tranquilizers may increase drowsiness

Stop use and ask a doctor if - Day Time

SPL UNCLASSIFIED SECTION

  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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 - Night Time

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.

If pregnant or breast-feeding, - Day Time

SPL UNCLASSIFIED SECTION

ask a health professional before use.

If pregnant or breast-feeding, - Night Time

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children. - Day Time

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning:

Taking more than directed can cause serious health problems. 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 & for children even if you do not notice any signs or symptoms.

Keep out of reach of children. - Night Time

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning:

Taking more than directed can cause serious health problems. 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 & for children even if you do not notice any signs or symptoms.

Directions - Day Time

DOSAGE & ADMINISTRATION SECTION

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

adults & children 12 yrs & over
2 capsules with water every 4 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use

  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing


Directions - Night Time

DOSAGE & ADMINISTRATION SECTION

  • take only as directed – see Overdose warning
  • do not exceed 4 doses per 24 hours

adults & children 12 yrs & over
2 capsules with water every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information - Day Time

STORAGE AND HANDLING SECTION

  • store at room temperature

Other information - Night Time

STORAGE AND HANDLING SECTION

  • store at room temperature

Inactive ingredients - Day Time

INACTIVE INGREDIENT SECTION

citric acid anhydrous, gelatin, glycerin, Neelicert FD & C Red No. 40, Neelicert FD & C Yellow No. 6, noncrystallizing sorbitol solution, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, titanium dioxide

Inactive ingredients - Night Time

INACTIVE INGREDIENT SECTION

D&C Yellow No. 10, gelatin, glycerin, Neelicert FD&C Blue No. 1, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-274-4122
 
Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-48 Capsule Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH
NDC 58602-770-54
 Daytime                                                          Nighttime
Compare to the active ingredients                    Compare to the active ingredients
in VICKS® DayQuil® Cold & Flu                  in VICKS® NyQuil® Cold & Flu 
Multi-Symptom Relief LiquiCaps®*                    Nighttime Relief LiquiCaps®*
Daytime Relief                                              Nighttime Relief
Cold & Flu                                                    Cold & Flu

Acetaminophen,                                             Acetaminophen,
Dextromethorphan HBr and                         Dextromethorphan HBr,
Phenylephrine HCl Capsules                        Doxylamine Succinate Capsules
325 mg/10 mg/5 mg                                        325 mg/15 mg/6.25 mg

     •  Aches, Fever &Sore Throat                 •  Aches, Fever & Sore Throat
     •   Nasal Congestion                                 •  Sneezing, Runny Nose
     •   Cough                                                   •  Cough

                                       32 Capsules               16 Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 48 Capsule BottlePACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 48 Capsule Bottle

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-77058602-770-54

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0ab835c5-0308-29eb-e063-6294a90a041b40e54c12-00d6-417c-96d4-1fcf5ca4f7d12023-11-22WarningsExact identifier
spl set id: 40e54c12-00d6-417c-96d4-1fcf5ca4f7d1

Reported adverse events (FAERS/openFDA)#

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