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 mg:

  Cough suppressant

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

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.

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

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.

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®
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

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)