COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF- acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate 
Aurohealth LLC

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Drug Facts - Day Time

Active ingredients (in each capsule)

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

Drug Facts - Night Time

Active ingredients (in each capsule)

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

Purpose - Day Time

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Purpose - Night Time

Pain reliever/fever reducer
Cough suppressant
Antihistamine



Uses - Day Time

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

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

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

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

  • 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

  • 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


  • 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

  • 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

taking the blood thinning drug warfarin.

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

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

When using this product,

do not use more than directed.

When using this product - Night Time

  • 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

  • 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

  • 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

ask a health professional before use.

If pregnant or breast-feeding, - Night Time

ask a health professional before use.

Keep out of reach of children. - Day Time

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

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

  • 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

  • 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

  • store at room temperature

Other information - Night Time

  • store at room temperature

Inactive ingredients - Day Time

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

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?

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


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-48 Capsule Carton

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                                              Nightt ime 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 Bottle

COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF 
acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-770
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-770-541 in 1 PACKAGE; Type 0: Not a Combination Product12/31/201911/15/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 116 BLISTER PACK 32 
Part 28 BLISTER PACK 16 
Part 1 of 2
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange (orange to reddish orange) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code Q01
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
116 in 1 CARTON
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/31/201911/15/2023
Part 2 of 2
NIGHTTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize20mm
FlavorImprint Code Q07
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 CARTON
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/31/201911/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/31/201911/15/2023
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777manufacture(58602-770)

Revised: 11/2023
 
Aurohealth LLC