Mucinex® Instasoothe™

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg)

Inactive Ingredients

Fd&c Red No. 40 Isomalt Propylene Glycol Fd&c Blue No. 1 Water Sucralose Hydrogenated Starch Hydrolysate

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-04-01

Medication Information

Description

Active Ingredient (in each Lozenge) Purpose Dextromethorphan HBr 5 mg Cough suppressant

Uses

Temporarily:

■ relieves cough due to minor throat and bronchial irritation as may occur with the common

cold or inhaled irritants

■ helps reduce the intensity of coughing

Section 42229-5

Dist. by: RB Health (US)

Parsippany, NJ 07054-0224

Made in India

2024 RB Health

Patents: www/reckitt.com/patents

www.mucinex.com

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 51945-4

NDC 72854-267-20

Mucinex®

INSTA>>SOOTHE® COUGH + SUGAR FREE

Dextromethorphan HBr 5 mg >> Cough Suppressant

Up to 4HR Relief

✔Quiets Cough

✔ Powerful Relief

✔ Long Lasting*”

20 MEDICATED DROPS - MIXED BERRY FLAVOR

Section 55105-1

Dextromethorphan HBr 5 mg: Cough suppressant

Section 55106-9

Active Ingredient

(in each Lozenge)

Purpose

Dextromethorphan HBr 5 mg

Cough suppressant

Warnings

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.

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 if 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 breastfeeding, ask a health professional before use.

Inactives

FD&C blue no. 1, FD&C red no. 40, flavors, hydrogenated starch

hydrolysate, isomalt, propylene glycol, purified water, sucralose

Questions

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

Directions

Other Infomation

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

Structured Label Content

Uses

Temporarily:

■ relieves cough due to minor throat and bronchial irritation as may occur with the common

cold or inhaled irritants

■ helps reduce the intensity of coughing

Section 42229-5 (42229-5)

Dist. by: RB Health (US)

Parsippany, NJ 07054-0224

Made in India

2024 RB Health

Patents: www/reckitt.com/patents

www.mucinex.com

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 51945-4 (51945-4)

NDC 72854-267-20

Mucinex®

INSTA>>SOOTHE® COUGH + SUGAR FREE

Dextromethorphan HBr 5 mg >> Cough Suppressant

Up to 4HR Relief

✔Quiets Cough

✔ Powerful Relief

✔ Long Lasting*”

20 MEDICATED DROPS - MIXED BERRY FLAVOR

Section 55105-1 (55105-1)

Dextromethorphan HBr 5 mg: Cough suppressant

Section 55106-9 (55106-9)

Active Ingredient

(in each Lozenge)

Purpose

Dextromethorphan HBr 5 mg

Cough suppressant

Warnings

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.

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 if 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 breastfeeding, ask a health professional before use.

Inactives

FD&C blue no. 1, FD&C red no. 40, flavors, hydrogenated starch

hydrolysate, isomalt, propylene glycol, purified water, sucralose

Questions

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

Directions

Other Infomation

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

Advanced Ingredient Data

[{"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOMALT", "unii": "S870P55O2W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYDROGENATED STARCH HYDROLYSATE", "unii": "27F77DSJ5V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily: ■ relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ helps reduce the intensity of coughing", "42229-5": "Dist. by: RB Health (US) Parsippany, NJ 07054-0224 Made in India 2024 RB Health Patents: www/reckitt.com/patents www.mucinex.com", "50565-1": "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away", "51945-4": "NDC 72854-267-20 Mucinex® INSTA>>SOOTHE® COUGH + SUGAR FREE Dextromethorphan HBr 5 mg >> Cough Suppressant Up to 4HR Relief ✔Quiets Cough ✔ Powerful Relief ✔ Long Lasting*” 20 MEDICATED DROPS - MIXED BERRY FLAVOR", "55105-1": "Dextromethorphan HBr 5 mg: Cough suppressant", "55106-9": "Active Ingredient (in each Lozenge) Purpose Dextromethorphan HBr 5 mg Cough suppressant", "Warnings": "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. 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 if 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 breastfeeding, ask a health professional before use.", "Inactives": "FD&C blue no. 1, FD&C red no. 40, flavors, hydrogenated starch hydrolysate, isomalt, propylene glycol, purified water, sucralose", "Questions": "1-866-MUCINEX (1-866-682-4639)", "Other Infomation": "store at 20-25°C (68-77°F) protect contents from humidity keep lozenge in outer pack until use. Reseal outer pack after use."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information