Delsym® Cough Plus™ Soothing Action

Drug Labeling and Warnings

Drug Details [pdf]

DELSYM  COUGH PLUS SOOTHING ACTION- dextromethorphan hydrobromide and menthol lozenge 
RB Health (US) 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

  • 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 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.

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

PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton

NDC: 63824-163-16

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

Sugar Free
Cherry

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: 63824-163
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeROUNDSize20mm
FlavorCHERRYImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63824-163-162 in 1 CARTON04/12/201306/01/2019
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/12/201306/01/2019
Labeler - RB Health (US) LLC (081049410)

Revised: 7/2019
Document Id: cf1234e7-ff27-470d-ba7e-0e237a16eedd
Set id: a2f61228-3d8f-4714-99db-18845cef1650
Version: 2
Effective Time: 20190703
 
RB Health (US) LLC