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NDC 58602-0770-54 COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF Details

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

COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. The primary component is .

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 58602-0770-54
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 58602-0770-54
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 58602-0770-54
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Doxylamine

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 58602-0770-54
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	58602-0770
Product ID	58602-770_cda9e381-24a3-4c53-8e25-b251a372983b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Aurohealth LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 58602-0770-54 (58602077054)

Pricing Information	N/A
NDC Package Code	58602-770-54
Billing NDC	58602077054
Package	1 KIT in 1 PACKAGE (58602-770-54) * 16 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK * 8 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK
Marketing Start Date	2019-12-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 40e54c12-00d6-417c-96d4-1fcf5ca4f7d1 Details

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

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                                              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

INGREDIENTS AND APPEARANCE

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

acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-770

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58602-770-54	1 in 1 PACKAGE; Type 0: Not a Combination Product	12/31/2019

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	16 BLISTER PACK	32
Part 2	8 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 Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	ORANGE (orange to reddish orange)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	Q01
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		16 in 1 CARTON
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	12/31/2019

Part 2 of 2
NIGHTTIME COLD AND FLU RELIEF acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	GREEN	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	Q07
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 in 1 CARTON
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	12/31/2019

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
APL HEALTHCARE LIMITED		650844777	MANUFACTURE(58602-770)

Revised: 12/2020

Document Id: cda9e381-24a3-4c53-8e25-b251a372983b

Set id: 40e54c12-00d6-417c-96d4-1fcf5ca4f7d1

Version: 2

Effective Time: 20201207