MUCINEX INSTASOOTHE COUGH- dextromethorphan hydrobromide lozenge

MUCINEX INSTASOOTHE by

Drug Labeling and Warnings

MUCINEX INSTASOOTHE by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

• Active Ingredient (in each Lozenge): Purpose
• Dextromethorphan HBr 5.0 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

PURPOSE

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.
■ in children under 6 years of age

Ask a doctor before use if:
■ 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.

Directions

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

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.

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)

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
Made in India
2024 RB Health
Patents: www/reckitt.com/patents
www.mucinex.com

PRINCIPAL DISPLAY PANEL

NDC: 72854-267-20

Mucinex®
INSTASOOTHE™ COUGH RELIEF

Dextromethorphan HBr 5.0 mg | Cough Suppressant

3 IN 1 FORMULA

✔ Quiets Cough
✔ Lasts up to 4 hours
✔ Sugar Free

See back
panel for
actual size

20 MEDICATED DROPS

INGREDIENTS AND APPEARANCE

MUCINEX INSTASOOTHE  COUGH
dextromethorphan hydrobromide lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-267
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
ISOMALT (UNII: S870P55O2W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-267-20	20 in 1 BAG	04/01/2024
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 72854-267-40	40 in 1 BAG	04/01/2024
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/01/2024

Labeler - RB Health (US) LLC (081049410)