DELSYM COUGH 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)	Purposes
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 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 headache that lasts. 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

• 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 between 20-25°C (68-77°F)

Inactive ingredients

D&C Yellow #10, FD&C Yellow #6, flavors, liquid glucose, propylene glycol, sucralose, sucrose, 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
Made in England

PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton

NDC: 63824-164-16

Delsym®

COUGH +™
SOOTHING
ACTION

LOZENGES

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

• ✓ Quiets Cough
• ✓ Relieves Sore Throat
• ✓ Soothing Action

16 LOZENGES

Honey
Lemon

INGREDIENTS AND APPEARANCE

DELSYM   COUGH PLUS SOOTHING ACTION
dextromethorphan hydrobromide and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-164
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 YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
propylene glycol (UNII: 6DC9Q167V3)
sucralose (UNII: 96K6UQ3ZD4)
sucrose (UNII: C151H8M554)
water (UNII: 059QF0KO0R)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	20mm
Flavor	HONEY, LEMON	Imprint Code	S
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-164-16	2 in 1 CARTON
1		8 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/12/2013

Labeler - Reckitt Benckiser LLC (094405024)