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Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time

Dosage form: kit
Ingredients: Dextromethorphan Hydrobromide 5mg in 5mL, Guaifenesin 100mg in 5mL; Acetaminophen 325mg in 10mL, Diphenhydramine Hydrochloride 12.5mg in 10mL, Phenylephrine Hydrochloride 5mg in 10mL
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-218

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.

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
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep

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
  • do not give more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
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
  • each 5 mL contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate

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, xanthan gum


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
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
  • temporarily reduces fever
  • controls cough to help your child get to sleep

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
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • measure only with the dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; not to exceed 5 doses in any 24-hour period
  • children under 6 years of age: do not use

Other information
  • each 10 mL contains: sodium 6 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate

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, xanthan gum


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

Made in England

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)

Relieves Cough
Relieves Chest
Congestion
Thins &
Loosens
Mucus

Cherry Flavor

For Ages
4
years+

COUGH+®Cold

Night Time

Acetaminophen (Pain Reliever/Fever Reducer)
Diphenhydramine HCl (Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)

Relieves Cough
Relieves
Stuffy Nose
Relieves
Sore Throat
Reduces Fever

Berry Flavor

For Ages
6
years+

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

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 Description
1NDC:63824-218-221 KIT in 1 CARTON
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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide5 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Anhydrous citric acid 
Edetate disodium 
FD&C RED NO. 40 
Glycerin 
Propyl gallate 
Propylene glycol 
Water 
Sodium benzoate 
Sorbitol 
Sucralose 
Trisodium citrate dihydrate 
Xanthan gum 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-214-64118 mL in 1 BOTTLE
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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg  in 10 mL
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride12.5 mg  in 10 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Anhydrous citric acid 
Edetate disodium 
FD&C Blue No. 1 
FD&C Red No. 40 
Glycerin 
Propyl gallate 
Propylene glycol 
Water 
Sodium benzoate 
Sorbitol 
Sucralose 
Trisodium citrate dihydrate 
Xanthan gum 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-212-64118 mL in 1 BOTTLE
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 - Reckitt Benckiser LLC (094405024)

Revised: 12/2017
 
Reckitt Benckiser LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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