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NDC 63824-0503-66 Mucinex Nightshift 650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL Details

Mucinex Nightshift 650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL

Mucinex Nightshift is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE.

Product Information

NDC	63824-0503
Product ID	63824-503_e9071387-8850-436c-badc-a087a899e0ac
Associated GPIs	43998903302020
GCN Sequence Number	080838
GCN Sequence Number Description	triprolidine/DM/acetaminophen LIQUID 2.5-650/20 ORAL
HIC3	B4G
HIC3 Description	NON-OPIOID ANTITUS-1ST GEN ANTIHIST-ANALGESIC COMB
GCN	47819
HICL Sequence Number	046405
HICL Sequence Number Description	TRIPROLIDINE HCL/DEXTROMETHORPHAN HBR/ACETAMINOPHEN
Brand/Generic	Brand
Proprietary Name	Mucinex Nightshift
Proprietary Name Suffix	Cold and Flu
Non-Proprietary Name	Acetaminophen, Dextromethorphan Hydrobromide, and Triprolidine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	650; 20; 2.5
Active Ingredient Units	mg/20mL; mg/20mL; mg/20mL
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	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	2024-12-31

Package

Package Images

NDC 63824-0503-66 (63824050366)

Pricing Information
NDC Package Code	63824-503-66
Billing NDC	63824050366
Package	180 mL in 1 BOTTLE (63824-503-66)
Marketing Start Date	2019-06-15
NDC Exclude Flag	N
Price Per Unit	0.05673
Pricing Unit	ML
Effective Date	2022-04-01
NDC Description	MUCINEX NIGHTSHIFT COLD-FLU LQ
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5, 6
Classification for Rate Setting	B
As of Date	2022-06-29

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL a51b6312-598e-4a25-a873-6b59bc87d900 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each 20 mL)	Purposes
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Triprolidine HCl 2.5 mg	Antihistamine

Uses

temporarily relieves these common cold and flu symptoms:
- cough
- minor aches and pains
- sore throat
- headache
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever
temporarily reduces fever
controls cough to help you get to sleep

Warnings

Liver warning

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

more than 4000 mg in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

do not use more than directed
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
use caution when driving a motor vehicle or operating machinery

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 fever, 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 the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed (see Overdose warning)
do not take more than 4 doses in any 24-hour period
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor
adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
children under 12 years of age: do not use

Other information

each 20 mL contains: sodium 16 mg
store at 20-25°C (68-77°F)
do not refrigerate

Inactive ingredients

ammonium glycyrrhizate, anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propylene glycol, sodium benzoate, sorbitol, sucralose, triacetin, triethyl citrate, water, xanthan gum

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)

Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

NDC 63824-503-66

Mucinex®

NIGHTSHIFT

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Triprolidine HCl – Antihistamine

NIGHT TIME

RELIEF FOR A BETTER

MORNING

✓COUGH ✓FEVER ✓SORE THROAT

✓RUNNY NOSE ✓SNEEZING

6 FL OZ (180 mL)

FOR AGES 12+

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

INGREDIENTS AND APPEARANCE

MUCINEX NIGHTSHIFT COLD AND FLU

acetaminophen, dextromethorphan hydrobromide, and triprolidine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-503
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 20 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63824-503-66	180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	06/15/2019
2	NDC:63824-503-69	266 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	06/15/2019
3	NDC:63824-503-64	1 in 1 CARTON	06/15/2019
3		118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/15/2019

Labeler - RB Health (US) LLC (081049410)

Revised: 1/2022

Document Id: e9071387-8850-436c-badc-a087a899e0ac

Set id: a51b6312-598e-4a25-a873-6b59bc87d900

Version: 2

Effective Time: 20220107

Search by Drug Name or NDC

NDC 63824-0503-66 Mucinex Nightshift 650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL Details

Mucinex Nightshift 650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL

Product Information

Package

Package Images

NDC 63824-0503-66 (63824050366)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a51b6312-598e-4a25-a873-6b59bc87d900 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Liver warning

Allergy alert

Sore throat warning

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

Overdose warning

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

INGREDIENTS AND APPEARANCE

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