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NDC 72854-0261-20 MUCINEX INSTASOOTHE 2.4 mg/1 Details

MUCINEX INSTASOOTHE 2.4 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 HEXYLRESORCINOL.

Product Information

NDC	72854-0261
Product ID	72854-261_9cafe349-407c-4f34-9825-03f4abcaf1c2
Associated GPIs	88150060004710
GCN Sequence Number	021874
GCN Sequence Number Description	hexylresorcinol LOZENGE 2.4 MG MUCOUS MEM
HIC3	B3K
HIC3 Description	COUGH AND/OR COLD PREPARATIONS
GCN	41041
HICL Sequence Number	000513
HICL Sequence Number Description	HEXYLRESORCINOL
Brand/Generic	Generic
Proprietary Name	MUCINEX INSTASOOTHE
Proprietary Name Suffix	SORE THROAT PLUS SOOTHING COMFORT
Non-Proprietary Name	HEXYLRESORCINOL
Product Type	HUMAN OTC DRUG
Dosage Form	LOZENGE
Route	ORAL
Active Ingredient Strength	2.4
Active Ingredient Units	mg/1
Substance Name	HEXYLRESORCINOL
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72854-0261-20 (72854026120)

Pricing Information
NDC Package Code	72854-261-20
Billing NDC	72854026120
Package	20 POUCH in 1 BAG (72854-261-20) / 1 LOZENGE in 1 POUCH
Marketing Start Date	2021-07-01
NDC Exclude Flag	N
Price Per Unit	0.1227
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	MUCINEX INSTASOOTHE CMFT 2.4 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 91cd2964-5d83-4e40-bc18-e3e5462f454a Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each lozenge)

Hexylresorcinol 2.4 mg

Purpose

Oral pain reliever

Uses

temporarily relieves occasional minor irritation and pain associated with

sore throat
sore mouth
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

in children under 6 years of age

When using this product do not exceed recommended dosage

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, rash, or fever develops

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

adults and children 6 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or directed by a doctor or dentist.
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, FD&C yellow no. 6, flavor, honey, 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 India

PRINCIPAL DISPLAY PANEL - 2.4 mg Pouch Bag

NDC 72854-261-20

Mucinex®

INSTASOOTHE™

SORE THROAT

+ SOOTHING COMFORT

Hexylresorcinol 2.4 mg | Oral Pain Reliever

3IN1 FORMULA

✓: Soothes Throat
✓: Relieves Sore Throat Pain
✓: Fast Acting

MADE

WITH

REAL

HONEY

See back

panel for

actual size

HONEY &

ECHINACEA FLAVOR

20 MEDICATED DROPS

PRINCIPAL DISPLAY PANEL - 2.4 mg Pouch Bag

INGREDIENTS AND APPEARANCE

MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT

hexylresorcinol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72854-261
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HEXYLRESORCINOL (UNII: R9QTB5E82N) (HEXYLRESORCINOL - UNII:R9QTB5E82N)	HEXYLRESORCINOL	2.4 mg

Ingredient Name	Strength
Inactive Ingredients
corn syrup (UNII: 9G5L16BK6N)
D&C yellow no. 10 (UNII: 35SW5USQ3G)
FD&C yellow no. 6 (UNII: H77VEI93A8)
honey (UNII: Y9H1V576FH)
propylene glycol (UNII: 6DC9Q167V3)
sucrose (UNII: C151H8M554)
water (UNII: 059QF0KO0R)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72854-261-20	20 in 1 BAG	07/01/2021
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC:72854-261-40	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: 5/2021

Document Id: 9cafe349-407c-4f34-9825-03f4abcaf1c2

Set id: 91cd2964-5d83-4e40-bc18-e3e5462f454a

Version: 1

Effective Time: 20210520

Search by Drug Name or NDC

NDC 72854-0261-20 MUCINEX INSTASOOTHE 2.4 mg/1 Details

MUCINEX INSTASOOTHE 2.4 mg/1

Product Information

Package

Package Images

NDC 72854-0261-20 (72854026120)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 91cd2964-5d83-4e40-bc18-e3e5462f454a Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each lozenge)

Purpose

Uses

Warnings

Sore throat warning

Do not use

Stop use and ask a doctor or dentist if

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 2.4 mg Pouch Bag

INGREDIENTS AND APPEARANCE

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