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NDC 72854-0263-40 MUCINEX INSTASOOTHE 5; 2 mg/1; mg/1 Details

MUCINEX INSTASOOTHE 5; 2 mg/1; mg/1

MUCINEX INSTASOOTHE is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; HEXYLRESORCINOL.

Product Information

NDC	72854-0263
Product ID	72854-263_8b2a3599-ea97-4eaf-bf5c-20eef840bda6
Associated GPIs	88209902214720
GCN Sequence Number	082552
GCN Sequence Number Description	dextromethorph/hexylresorcinol LOZENGE 5 MG-2 MG ORAL
HIC3	H6C
HIC3 Description	ANTITUSSIVES, NON-OPIOID
GCN	50004
HICL Sequence Number	047517
HICL Sequence Number Description	DEXTROMETHORPHAN HBR/HEXYLRESORCINOL
Brand/Generic	Brand
Proprietary Name	MUCINEX INSTASOOTHE
Proprietary Name Suffix	SORE THROAT PLUS COUGH RELIEF
Non-Proprietary Name	DEXTROMETHORPHAN HYDROBROMIDE and HEXYLRESORCINOL
Product Type	HUMAN OTC DRUG
Dosage Form	LOZENGE
Route	ORAL
Active Ingredient Strength	5; 2
Active Ingredient Units	mg/1; mg/1
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; HEXYLRESORCINOL
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 NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72854-0263-40 (72854026340)

Pricing Information
NDC Package Code	72854-263-40
Billing NDC	72854026340
Package	40 POUCH in 1 BAG (72854-263-40) / 1 LOZENGE in 1 POUCH
Marketing Start Date	2021-07-01
NDC Exclude Flag	N
Price Per Unit	0.12311
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	MUCINEX INSTASOOTH COUGH 5-2 MG
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 6
Classification for Rate Setting	B
As of Date	2024-02-21

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 8d670d91-9e22-45b9-b568-5b62c2133d32 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each lozenge)	Purposes
Dextromethorphan HBr 5.0 mg	Cough suppressant
Hexylresorcinol 2.0 mg	Oral pain reliever

Uses

temporarily relieves

cough due to minor throat and bronchial irritation as may occur with the common cold
occasional irritation and pain due to a sore mouth or sore throat
pain associated with canker sores

Warnings

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Do not use

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.
in children under 6 years of age

When using this product do not exceed recommended dosage

Ask a doctor before use if you have

persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor or dentist if

sore mouth symptoms do not improve in 7 days
irritation, pain, or redness persists or worsens
swelling develops
cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

dose as follows or as directed by a doctor or dentist

adults and children 12 years of age and older	take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 12 lozenges in any 24-hour period
children 6 to under 12 years of age	take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in any 24-hour period
children under 6 years of age	do not use

Other information

store at 20-25°C (68-77°F)
protect contents from humidity

Inactive ingredients

corn syrup, D&C yellow no. 10, ethyl lactate, FD&C blue no. 1, flavor, propylene glycol, sucrose, water

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

Made in Thailand

PRINCIPAL DISPLAY PANEL - 20 Drop Pouch Bag

NDC 72854-263-20

Mucinex®

INSTASOOTHE™

SORE THROAT

+ COUGH RELIEF

Dextromethorphan HBr 5.0 mg | Cough Suppressant

Hexylresorcinol 2.0 mg | Oral Pain Reliever

3 IN 1 FORMULA

✔ Quiets Cough

✔ Cooling Comfort

✔ Fast Acting

See back

panel for

actual size

ALPINE HERBS &

FRESH MINT FLAVOR

20 MEDICATED DROPS

PRINCIPAL DISPLAY PANEL - 20 Drop Pouch Bag

INGREDIENTS AND APPEARANCE

MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF

dextromethorphan hydrobromide and hexylresorcinol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72854-263
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg
HEXYLRESORCINOL (UNII: R9QTB5E82N) (HEXYLRESORCINOL - UNII:R9QTB5E82N)	HEXYLRESORCINOL	2 mg

Ingredient Name	Strength
Inactive Ingredients
corn syrup (UNII: 9G5L16BK6N)
D&C yellow no. 10 (UNII: 35SW5USQ3G)
ethyl lactate (UNII: F3P750VW8I)
FD&C blue no. 1 (UNII: H3R47K3TBD)
propylene glycol (UNII: 6DC9Q167V3)
sucrose (UNII: C151H8M554)
water (UNII: 059QF0KO0R)

Product Characteristics
Color	TURQUOISE	Score	no score
Shape	ROUND	Size	18mm
Flavor	MINT	Imprint Code	S
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72854-263-20	20 in 1 BAG	07/01/2021
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC:72854-263-40	40 in 1 BAG	07/01/2021
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	07/01/2021

Labeler - RB Health (US) LLC (081049410)

Revised: 6/2021

Document Id: 8b2a3599-ea97-4eaf-bf5c-20eef840bda6

Set id: 8d670d91-9e22-45b9-b568-5b62c2133d32

Version: 1

Effective Time: 20210617

Search by Drug Name or NDC

NDC 72854-0263-40 MUCINEX INSTASOOTHE 5; 2 mg/1; mg/1 Details

MUCINEX INSTASOOTHE 5; 2 mg/1; mg/1

Product Information

Package

Package Images

NDC 72854-0263-40 (72854026340)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 8d670d91-9e22-45b9-b568-5b62c2133d32 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Sore throat warning

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor or dentist if

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 20 Drop Pouch Bag

INGREDIENTS AND APPEARANCE

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