CHILDRENS DELSYM COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin solution 
RB Health (US) LLC

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Children's Delsym ®

Cough Plus ® Chest Congestion DM

Drug Facts

Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant

Uses

Warnings

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

When using this product do not use more than directed

Stop use and ask a doctor if

  • 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.

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

Directions

Age (year)Dose (mL)
children 6 to under 12 years of age5 mL - 10 mL every 4 hours
children 4 to under 6 years of age2.5 mL - 5 mL every 4 hours
children under 4 years of agedo not use

Other information

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate 1, xanthan gum


1
may contain this ingredient

Questions?

1-866-682-4639

You may also report side effects to this phone number.

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 63824-214-64

Ages 4 Years +

Children's

Delsym ®

COUGH + ®

Chest Congestion

DM

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

Cherry Flavor

4 fl oz (118 mL) Label

CHILDRENS DELSYM  COUGH PLUS CHEST CONGESTION DM
dextromethorphan hydrobromide and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-214
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-214-66180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)03/31/201308/31/2019
2NDC:63824-214-641 in 1 CARTON06/08/2017
2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/31/2013
Labeler - RB Health (US) LLC (081049410)

Revised: 6/2024
Document Id: 1bf80730-b2e0-9f0e-e063-6394a90a480a
Set id: d26b5143-aa07-4114-a6ba-4f503aadd46f
Version: 7
Effective Time: 20240628
 
RB Health (US) LLC