Mucinex® Instasoothe™

SPL v3

SPL

SPL Set ID 8d670d91-9e22-45b9-b568-5b62c2133d32

Route

ORAL

Published

Effective Date 2021-06-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Hexylresorcinol (2 mg)

Inactive Ingredients

Corn Syrup D&c Yellow No. 10 Ethyl Lactate Fd&c Blue No. 1 Propylene Glycol Sucrose Water

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-07-01

Description

Drug Facts

Medication Information

Description

Drug Facts

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

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.

Section 55105-1

Active ingredients (in each lozenge)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Hexylresorcinol 2 mg	Oral pain reliever

Section 55106-9

Active ingredients (in each lozenge)

Dextromethorphan HBr 5 mg

Hexylresorcinol 2 mg

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

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

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, ethyl lactate, FD&C blue no. 1, flavor, propylene glycol, purified water, sucrose.

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.

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

✔ Up to 4 Hours Cough Relief

✔ Cooling Comfort

✔ Fast Acting

See back

panel for

actual size

Winter Mint Flavor

20 MEDICATED DROPS

Structured Label Content

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

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.

Section 55105-1 (55105-1)

Active ingredients (in each lozenge)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Hexylresorcinol 2 mg	Oral pain reliever

Section 55106-9 (55106-9)

Active ingredients (in each lozenge)

Dextromethorphan HBr 5 mg

Hexylresorcinol 2 mg

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

Do Not Use (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

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, ethyl lactate, FD&C blue no. 1, flavor, propylene glycol, purified water, sucrose.

Ask A Doctor Before Use If You Have (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 (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.

Principal Display Panel 20 Drop Pouch Bag (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

✔ Up to 4 Hours Cough Relief

✔ Cooling Comfort

✔ Fast Acting

See back

panel for

actual size

Winter Mint 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": "ETHYL LACTATE", "unii": "F3P750VW8I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "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": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HEXYLRESORCINOL", "unii": "R9QTB5E82N", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "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.", "55105-1": "Active ingredients (in each lozenge) Purposes Dextromethorphan HBr 5 mg Cough suppressant Hexylresorcinol 2 mg Oral pain reliever", "55106-9": "Active ingredients (in each lozenge) Dextromethorphan HBr 5 mg Hexylresorcinol 2 mg", "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", "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", "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, ethyl lactate, FD&C blue no. 1, flavor, propylene glycol, purified water, sucrose.", "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.", "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 ✔ Up to 4 Hours Cough Relief ✔ Cooling Comfort ✔ Fast Acting See back panel for actual size Winter Mint Flavor 20 MEDICATED DROPS"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:52.938474 · Updated: 2026-03-14T23:08:17.487612