DELSYM COUGH RELIEF PLUS SOOTHING ACTION- dextromethorphan hydrobromide and menthol lozenge

Delsym by

Drug Labeling and Warnings

Delsym by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each lozenge)	Purpose
Dextromethorphan HBr 5 mg	Cough suppressant
Menthol 5 mg	Oral pain reliever

Uses

temporarily relieves

• sore throat
• sore mouth
• minor mouth irritation
• cough due to minor throat and bronchial irritation as may occur with the common cold

Warnings

Sore throat warning

• If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.

Do not use in a child under 6 years of age.

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 is accompanied by excessive 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 illness

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

Keep this and all drugs out of the reach of children.

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

Directions

• adults and children 12 years 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, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctor
• children 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor
• children under 6 years of age: do not use

Other information

• tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing.
• store at room temperature 20-25°C (68-77°F)

Inactive ingredients

D&C red #33, FD&C red #40, flavors, isomalt, maltitol syrup, propylene glycol, sorbitol, sucralose, water

Questions?

Call 1-888-963-3382

You may also report side effects to this phone number.

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Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack

NDC: 63824-161-16

NEW!

Delsym®

COUGH RELIEF PLUS
SOOTHING ACTION

Dextromethorphan HBr 5 mg (Cough Suppressant)
Menthol 5 mg (Oral Pain Reliever)

• Quiets cough
• Relieves sore throat
• Soothing action

16 LOZENGES

Sugar Free
Cherry

INGREDIENTS AND APPEARANCE

DELSYM   COUGH RELIEF PLUS SOOTHING ACTION
dextromethorphan hydrobromide and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-161
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
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg

Inactive Ingredients
Ingredient Name	Strength
D&C red no. 33 (UNII: 9DBA0SBB0L)
FD&C red no. 40 (UNII: WZB9127XOA)
isomalt (UNII: S870P55O2W)
propylene glycol (UNII: 6DC9Q167V3)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)
water (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	27mm
Flavor	CHERRY	Imprint Code	D
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-161-16	16 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/01/2012

Labeler - Reckitt Benckiser LLC (094405024)