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NDC 58602-0768-15 DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF 325; 10; 5 mg/1; mg/1; mg/1 Details

DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF 325; 10; 5 mg/1; mg/1; mg/1

DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.

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: 58602-0768-15
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: 58602-0768-15
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

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: 58602-0768-15
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	58602-0768
Product ID	58602-768_f9ab5a36-5608-4d0d-9465-bd497382f6bb
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	DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	325; 10; 5
Active Ingredient Units	mg/1; mg/1; mg/1
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Aurohealth LLC
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 58602-0768-15 (58602076815)

Pricing Information	N/A
NDC Package Code	58602-768-15
Billing NDC	58602076815
Package	16 CAPSULE in 1 BOTTLE (58602-768-15)
Marketing Start Date	2019-12-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8eaa0eec-cc52-4f1f-8ddb-06c54d577ce2 Details

Active ingredients (in each capsule)

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Phenylephrine HCl USP 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

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

more than 4 doses 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

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

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 or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

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

Other information

store at room temperature

Inactive ingredients

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

Questions or comments?

call 1-855-274-4122

SPL UNCLASSIFIED SECTION

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - (16 Capsules Bottle)

AUROHEALTH

NDC 58602-768-15

Compare to the active ingredients

in VICKS® DayQuil® Cold & Flu

Multi-Symptom Relief LiquiCaps®*

Multi-Symptom Relief

Non-Drowsy

Daytime Relief

Cold & Flu

Acetaminophen, Dextromethorphan HBr and

Phenylephrine HCl Capsules

325 mg/10 mg/5 mg

Aches, Fever & Sore Throat
Nasal Congestion
Cough

16 Capsules

INGREDIENTS AND APPEARANCE

DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF

acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-768
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 Brown)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	Q01
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58602-768-15	16 in 1 BOTTLE; Type 0: Not a Combination Product	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(58602-768)

Revised: 12/2020

Document Id: f9ab5a36-5608-4d0d-9465-bd497382f6bb

Set id: 8eaa0eec-cc52-4f1f-8ddb-06c54d577ce2

Version: 2

Effective Time: 20201207