CHILDRENS DELSYM COUGH PLUS CHEST CONGESTION DM AND DELSYM COUGH PLUS COLD NIGHT TIME- acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit

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

Drug Labeling and Warnings

Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

COUGH+ CHEST CONGESTION DM - AGES 4+

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.

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

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 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

SPL UNCLASSIFIED SECTION

COUGH+ COLD NIGHT TIME - AGES 6+

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 mL)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg	Antihistamine/cough suppressant
Phenylephrine HCl 5 mg	Nasal 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 dihyrate2, xanthan gum

2 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 - Kit Carton

NDC: 63824-218-22

DAY
NIGHT

COMBO
PACK

Children's
Delsym®

COUGH+®
Chest Congestion

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)

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-218

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 63824-218-22	1 in 1 CARTON	07/01/2017

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	118 mL
Part 2	1 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 Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	07/08/2017

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 Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg in 10 mL
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	12.5 mg in 10 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
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
Color	BLUE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	07/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	07/01/2017

Labeler - RB Health (US) LLC (081049410)