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NDC 58602-0769-15 NIGHTTIME COLD AND FLU RELIEF 325; 15; 6.25 mg/1; mg/1; mg/1 Details

NIGHTTIME COLD AND FLU RELIEF 325; 15; 6.25 mg/1; mg/1; mg/1

NIGHTTIME COLD AND FLU 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; DOXYLAMINE SUCCINATE.

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: 58602-0769-15
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: 58602-0769-15
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: 58602-0769-15
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Doxylamine

Product Information

NDC	58602-0769
Product ID	58602-769_06f99aa0-6054-4919-9bf9-150c2f336d65
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	NIGHTTIME COLD AND FLU RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	325; 15; 6.25
Active Ingredient Units	mg/1; mg/1; mg/1
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Labeler Name	Aurohealth LLC
Pharmaceutical Class	Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 58602-0769-15 (58602076915)

Pricing Information	N/A
NDC Package Code	58602-769-15
Billing NDC	58602076915
Package	16 CAPSULE in 1 BOTTLE (58602-769-15)
Marketing Start Date	2019-12-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 70e1bd25-c32e-491f-b383-91d6f74957a0 Details

Active ingredients (in each capsule)

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 15 mg

Doxylamine succinate USP 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

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

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.
to make a child sleep

Ask a doctor before use if you have

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

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product, 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

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,

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 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

store at room temperature

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

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

AUROHEALTH

NDC 58602-769-15

Compare to the active ingredients

in VICKS® NyQuil® Cold & Flu

Nighttime Relief LiquiCaps®*

Nighttime Relief

Cold & Flu

Acetaminophen, Dextromethorphan HBr and

Doxylamine Succinate Capsules

325 mg/15 mg/6.25 mg

Aches, Fever & Sore Throat
Sneezing, Runny Nose
Cough

16 Capsules

INGREDIENTS AND APPEARANCE

NIGHTTIME COLD AND FLU RELIEF

acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-769
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	NDC:58602-769-15	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(58602-769)

Revised: 12/2020

Document Id: 06f99aa0-6054-4919-9bf9-150c2f336d65

Set id: 70e1bd25-c32e-491f-b383-91d6f74957a0

Version: 2

Effective Time: 20201207