DELSYM  COUGH PLUS SOOTHING ACTION- dextromethorphan hydrobromide and menthol lozenge 
Reckitt Benckiser LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Delsym®
Cough Plus™ Soothing Action

Drug Facts

Active ingredients (in each lozenge)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Menthol 5 mgOral pain reliever

Uses

temporarily relieves

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

Other information

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.

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

Principal Display Panel - 16 Lozenge Carton
DELSYM   COUGH PLUS SOOTHING ACTION
dextromethorphan hydrobromide and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-164
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOWScoreno score
ShapeROUNDSize20mm
FlavorHONEY, LEMONImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-164-162 in 1 CARTON
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/12/2013
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 5/2013
Document Id: c730b29f-b926-40bf-980f-a1a8604bbd2b
Set id: ba0ef46a-c066-47f8-a9d5-d7192adc6c6a
Version: 1
Effective Time: 20130501
 
Reckitt Benckiser LLC