CHILDRENS DELSYM COUGH PLUS CHEST CONGESTION DM AND DELSYM COUGH PLUS COLD NIGHT TIME- acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride 
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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Children's Delsym ® Cough Plus ® Chest Congestion DM and Delsym Cough Plus ® Cold Night Time

COUGH+ CHEST CONGESTION DM - AGES 4+

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

COUGH+ COLD NIGHT TIME - AGES 6+

Drug Facts

Active ingredients (in each 10 mL)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Diphenhydramine HCl 12.5 mgAntihistamine/cough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on the skin
  • 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

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child is

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • do not use more than directed (see Overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough 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.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihyrate 2, xanthan gum


2
may contain this ingredient

Questions?

1-866-682-4639

You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser

Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 63824-218-22

DAY

NIGHT

COMBO

PACK

Children's

Delsym ®

COUGH+ ®

Chest Congestion

DM

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

Cherry Flavor

For Ages

4

years+

COUGH+ ®Cold

Night Time

Acetaminophen (Pain Reliever/Fever Reducer)

Diphenhydramine HCl (Antihistamine/Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Berry Flavor

For Ages

6

years+

TWO - 4 fl oz (118 mL) bottles TOTAL - 8 fl oz (236 mL)

Label

CHILDRENS DELSYM COUGH PLUS CHEST CONGESTION DM AND DELSYM COUGH PLUS COLD NIGHT TIME 
acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-218
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-218-221 in 1 CARTON07/01/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 21 BOTTLE 118 mL
Part 1 of 2
CHILDRENS DELSYM   COUGH PLUS CHEST CONGESTION DM
dextromethorphan hydrobromide and guaifenesin solution
Product Information
Item 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)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
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
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/08/2017
Part 2 of 2
CHILDRENS DELSYM   COUGH PLUS COLD NIGHT TIME
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution
Product Information
Item Code (Source)NDC:63824-212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/13/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2017
Labeler - RB Health (US) LLC (081049410)

Revised: 2/2023
Document Id: f5b5b2d7-230a-a0f0-e053-2995a90aa287
Set id: 9aca1a68-893c-4770-8a48-d5d678058253
Version: 4
Effective Time: 20230227
 
RB Health (US) LLC