Mucinex® Instasoothe™

SPL v4

SPL

SPL Set ID 91cd2964-5d83-4e40-bc18-e3e5462f454a

Route

ORAL

Published

Effective Date 2021-05-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hexylresorcinol (2.4 mg)

Inactive Ingredients

Corn Syrup D&c Yellow No. 10 Fd&c Yellow No. 6 Honey Propylene Glycol Sucrose Water

Identifiers & Packaging

Pill Appearance

Imprint: S Shape: round Color: yellow Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-07-01 Until 2024-09-09

Description

Drug Facts

Purpose

Oral pain reliever

Medication Information

Purpose

Oral pain reliever

Description

Drug Facts

Uses

temporarily relieves occasional minor irritation and pain associated with

sore throat
sore mouth
canker sores

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this productdo not exceed recommended dosage

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

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

Do Not Use

in children under 6 years of age

Questions?

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

Other Information

store at 20-25°C (68-77°F)
protect contents from humidity
Keep lozenge in outer pack until use. Reseal outer pack after use.

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.

Inactive Ingredients

corn syrup, D&C yellow no. 10, FD&C yellow no. 6, flavor, honey, propylene glycol, purified water, sucrose

Active Ingredient (in Each Lozenge)

Hexylresorcinol 2.4 mg

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

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

See back

panel for

actual size

HONEY &

ECHINACEA FLAVOR

20 MEDICATED DROPS

Structured Label Content

Uses

temporarily relieves occasional minor irritation and pain associated with

sore throat
sore mouth
canker sores

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this productdo not exceed recommended dosage

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Oral pain reliever

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

Do Not Use (Do not use)

in children under 6 years of age

Questions?

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

Other Information (Other information)

store at 20-25°C (68-77°F)
protect contents from humidity
Keep lozenge in outer pack until use. Reseal outer pack after use.

Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

corn syrup, D&C yellow no. 10, FD&C yellow no. 6, flavor, honey, propylene glycol, purified water, sucrose

Active Ingredient (in Each Lozenge) (Active ingredient (in each lozenge))

Hexylresorcinol 2.4 mg

Stop Use and Ask A Doctor Or Dentist If (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

Principal Display Panel 2.4 Mg Pouch Bag (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

See back

panel for

actual size

HONEY &

ECHINACEA FLAVOR

20 MEDICATED DROPS

Advanced Ingredient Data

[{"name": "CORN SYRUP", "unii": "9G5L16BK6N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HONEY", "unii": "Y9H1V576FH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HEXYLRESORCINOL", "unii": "R9QTB5E82N", "classCode": "ACTIB", "strengthNumerator": "2.4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves occasional minor irritation and pain associated with sore throat sore mouth canker sores", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product do not exceed recommended dosage", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Oral pain reliever", "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", "Do not use": "in children under 6 years of age", "Questions?": "1-866-MUCINEX (1-866-682-4639)", "Other information": "store at 20-25°C (68-77°F) protect contents from humidity Keep lozenge in outer pack until use. Reseal outer pack after use.", "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.", "Inactive ingredients": "corn syrup, D&C yellow no. 10, FD&C yellow no. 6, flavor, honey, propylene glycol, purified water, sucrose", "Active ingredient (in each lozenge)": "Hexylresorcinol 2.4 mg", "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", "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 See back panel for actual size HONEY & ECHINACEA FLAVOR 20 MEDICATED DROPS"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:52.941511 · Updated: 2026-03-14T23:08:17.487612