CHILDRENS DELSYM COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin solution

Childrens Delsym by

Drug Labeling and Warnings

Childrens Delsym by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant

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 take 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 age	5 mL - 10 mL every 4 hours
children 4 to under 6 years of age	2.5 mL - 5 mL every 4 hours
children under 4 years of age	do 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 dihydrate1, xanthan gum

1 may contain this ingredient

Questions?

1-866-682-4639

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

031113
8079219

Children's
Delsym®

NDC: 63824-214-66

COUGH + ™
CHEST
CONGESTION

DM

Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)

Age 4+

• ✓ Cough
• ✓ Chest Congestion
• ✓ Thins & Loosens
  Mucus

6 fl oz (180 mL)

Cherry Flavor

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)

• ✓ Relieves Cough
• ✓ Relieves Chest
  Congestion
• ✓ Thins &
  Loosens
  Mucus

Cherry Flavor

4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS DELSYM   COUGH PLUS CHEST CONGESTION DM
dextromethorphan hydrobromide and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-214
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	5 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-214-66	180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	03/31/2013
2	NDC: 63824-214-64	1 in 1 CARTON	06/08/2017
2		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/31/2013

Labeler - Reckitt Benckiser LLC (094405024)