MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF- dextromethorphan hydrobromide and hexylresorcinol 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]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each lozenge)	Purposes
Dextromethorphan HBr 5.0 mg	Cough suppressant
Hexylresorcinol 2.0 mg	Oral pain reliever

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

Warnings

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.

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

When using this productdo not exceed recommended dosage

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.

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

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

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

Other information

• store at 20-25°C (68-77°F)
• protect contents from humidity

Inactive ingredients

corn syrup, D&C yellow no. 10, ethyl lactate, FD&C blue no. 1, flavor, propylene glycol, purified water, sucrose.

Questions?

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

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Dist. by: RB Health (US)
Parsippany,
NJ 07054-0224
Made in Thailand

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

INGREDIENTS AND APPEARANCE

MUCINEX INSTASOOTHE  SORE THROAT PLUS COUGH RELIEF
dextromethorphan hydrobromide and hexylresorcinol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-263
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
HEXYLRESORCINOL (UNII: R9QTB5E82N) (HEXYLRESORCINOL - UNII:R9QTB5E82N)	HEXYLRESORCINOL	2 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ETHYL LACTATE (UNII: F3P750VW8I)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-263-20	20 in 1 BAG	07/01/2021
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 72854-263-40	40 in 1 BAG	07/01/2021
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	M022	07/01/2021

Labeler - RB Health (US) LLC (081049410)