ROBITUSSIN CHILDRENS HONEY DAY NIGHT DM VALUE PACK- dextromethorphan hbr, guaifenesin, doxylamine succinate kit

Robitussin by

Drug Labeling and Warnings

Robitussin by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 10 mL) – Children’s Robitussin Honey Cough & Chest Congestion DM

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Purposes – Children’s Robitussin Honey Cough & Chest Congestion DM

Cough Suppressant

Expectorant

Uses – Children’s Robitussin Honey Cough & Chest Congestion DM

• ▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• ▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tube

Warnings – Children’s Robitussin Honey Cough & Chest Congestion DM

Do not use

if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if you have

• ▪ cough that occurs with too much phlegm (mucus)
• ▪ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions – Children’s Robitussin Honey Cough & Chest Congestion DM

• ▪ do not take more than 6 doses in any 24-hour period
• ▪ measure only with dosing cup provided
• ▪ keep dosing cup with product
• ▪ mL = milliliter

• age:

  dose

• children under 4 years:

  do not use

• children 4 to under 6 years:

  5 mL every 4 hours

• children 6 to under 12 years:

  10 mL every 4 hours

• adults and children 12 years and over:

  20 mL every 4 hours

Other information – Children’s Robitussin Honey Cough & Chest Congestion DM

• ▪ each 10 mL contains: sodium 11 mg
• ▪ store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients – Children’s Robitussin Honey Cough & Chest Congestion DM

anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Questions or comments? – Children’s Robitussin Honey Cough & Chest Congestion DM

call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

Active ingredients (in each 10 mL) – Children’s Robitussin Honey NighttimeCough DM

Dextromethorphan HBr, USP 15 mg

Doxylamine succinate, USP 6.25 mg

Purposes – Children’s Robitussin Honey Nighttime Cough DM

Cough suppressant

Antihistamine

Uses – Children’s Robitussin Honey Nighttime Cough DM

• ▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• ▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • ▪ runny nose
  • ▪ sneezing
  • ▪ itchy, watery eyes
  • ▪ itching of the nose or throat
• ▪ controls the impulse to cough to help you sleep

Warnings – Children’s Robitussin Honey Nighttime Cough DM

Do not use

• ▪ to sedate a child or to make a child sleepy
• ▪ if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• ▪ trouble urinating due to an enlarged prostate gland
• ▪ glaucoma
• ▪ a cough that occurs with too much phlegm (mucus)
• ▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

• ▪ do not use more than directed
• ▪ marked drowsiness may occur
• ▪ avoid alcoholic drinks
• ▪ alcohol, sedatives, and tranquilizers may increase drowsiness
• ▪ be careful when driving a motor vehicle or operating machinery
• ▪ excitability may occur, especially in children

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions – Children’s Robitussin Honey Nighttime Cough DM

measure only with dosing cup provided

keep dosing cup with product

mL = milliliter

do not take more than 4 doses in any 24-hour period

• age:

  dose

• children under 6 years:

  do not use

• children 6 to 12 years:

  10 mL every 6 hours

• adults and children 12 years and older:

  20 mL every 6 hours

Other information– Children’s Robitussin Honey Nighttime Cough DM

• ▪ each 10 mL contains: sodium 10 mg
• ▪ store at 20-25°C (68-77°F)

Inactive ingredients– Children’s Robitussin Honey Nighttime Cough DM

anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Questions or comments? – Children’s Robitussin Honey Nighttime Cough DM

call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

Additional Information

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

Do not take both products within 6 hours of each other.

Honey

This dynamic duo combines the great taste of natural honey with the effective cough relief of Robitussin you trust to help your child feel better.

Made with Real Honey

TRUE SOURCE CERTIFIED HONEY

Gluten Free

No Artificial Colors

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel – Children’s Robitussin Honey Day Night Value Pack

Value Pack

Day Night

Children’s

Robitussin

Honey

For Ages 4+

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Relieves:

• ✓ Chest congestion
• ✓ Mucus
• ✓ Cough

Taste the Real Honey

TRUE SOURCE CERTIFIED HONEY

4 FL OZ (118 mL)

Children’s

Robitussin

Honey

For ages 6+

Nighttime Cough DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

ALCOHOL FREE

LONG-ACTING

Relieves:

Cough up to 8 hours

Runny nose

Taste the Real Honey

TRUE SOURCE CERTIFIED HONEY

4 FL OZ (118 mL)

Principal Display Panel – Children’s Robitussin Honey Cough & Chest Congestion DM

Children’s

Robitussin

Honey

For Ages 4+

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Relieves:

• ✓ Chest congestion
• ✓ Mucus
• ✓ Cough

Taste the Real Honey

TRUE SOURCE CERTIFIED HONEY

4 FL OZ (118 mL)

Principal Display Panel – Children’s Robitussin Honey Nighttime Cough DM

Children’s

Robitussin

Honey

For ages 6+

Nighttime Cough DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

ALCOHOL FREE

LONG-ACTING

Relieves:

Cough up to 8 hours

Runny nose

Taste the Real Honey

TRUE SOURCE CERTIFIED HONEY

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

ROBITUSSIN  CHILDRENS HONEY DAY NIGHT DM VALUE PACK
dextromethorphan hbr, guaifenesin, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-2102

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-2102-01	1 in 1 CARTON; Type 0: Not a Combination Product	05/27/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 BOTTLE	1 mL
Part 2	0 BOTTLE	1 mL

Part 1 of 2

CHILDRENS ROBITUSSIN HONEY COUGH AND CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin solution

Product Information
Item Code (Source)	NDC: 0031-8760
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
HONEY (UNII: Y9H1V576FH)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8760-12	1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/25/2018

Part 2 of 2

CHILDRENS ROBITUSSIN HONEY NIGHTTIME COUGH DM 
dextromethorphan hbr, doxylamine succinate solution

Product Information
Item Code (Source)	NDC: 0031-8762
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 10 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
HONEY (UNII: Y9H1V576FH)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8762-12	1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/27/2019

Labeler - Haleon US Holdings LLC (079944263)