ROBITUSSIN DAY AND NIGHT COUGH RELIEF VALUE PACK- dextromethorphan hydrobromide, guaifenesin, chlorpheniramine maleate 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 20 mL)– Children’s Robitussin Cough & Chest Congestion DM

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Purposes– Children’s Robitussin Cough & Chest Congestion DM

Cough Suppressant

Expectorant

Uses– Children’s Robitussin 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 tubes

Warnings– Children’s Robitussin 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 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 Cough & Chest Congestion DM

• each 20 mL contains:sodium 21 mg
• store at 20-25°C (68-77°F). Do not refrigerate.

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

anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum

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

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

Active ingredients (in each 10 mL)– Children’s Robitussin Nighttime Cough Long-Acting DM

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

Purposes –Children’s Robitussin Nighttime Cough Long-Acting DM

Antihistamine

Cough suppressant

Uses –Children’s Robitussin Nighttime Cough Long-Acting 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

Warnings– Children’s Robitussin Nighttime Cough Long-Acting 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 Nighttime Cough Long-Acting 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 under 12 years:

  10 mL every 6 hours

• adults and children 12 years and over:

  20 mL every 6 hours

Other information –Children’s Robitussin Nighttime Cough Long-Acting DM

• each 10 mL contains:sodium 6 mg
• store at 20-25°C (68-77°F)

Inactive ingredients –Children’s Robitussin Nighttime Cough Long-Acting DM

anhydrous citric acid, FD&C red no. 40, glycerin, lactic acid, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments? –Children’s Robitussin Nighttime Cough Long-Acting DM

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

Additional Information – Children’s Robitussin Day & Night Cough Relief Value Pack

TAMPER-EVIDENT INNER UNITS:

Do Not Use if Tamper-Evident feature on either bottle cap is broken or missing. See individual inner cartons and bottle labels for specific Tamper-Evident features.

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

Children’s Robitussin liquid is specially formulated to provide soothing action, control your child’s cough – plus relieves other cold symptoms.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel – Children’s Robitussin Day & Night Cough Relief Value Pack

DAY & NIGHT

COUGH RELIEF

VALUE PACK

Children’s Robitussin

AGES 4 & OVER

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN

(Expectorant)

Relieves:

• Chest Congestion/Mucus
• Cough

grapeflavor

4 FL OZ (118 mL)

AGES 6 & OVER

Nighttime Cough Long-Acting DM

CHLORPHENIRAMINE MALEATE

(Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

• Cough Up to 8 Hours
• Runny Nose

Alcohol-free

fruit punchflavor

4 FL OZ (118 mL)

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

Children’s

Robitussin

FOR AGES 4 & OVER

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr
(Cough Suppressant)

GUAIFENESIN
(Expectorant)

Relieves:

• Chest Congestion/Mucus
• Cough

BETTER TASTING!*

Great Grape Taste

grapeflavor

4 FL OZ (118 mL)

Principal Display Panel – Children’s Robitussin Nighttim e Cough DM

Children’s

Robitussin

AGES 6 & OVER

Nighttime Cough DM

Long-Acting

CHLORPHENIRAMINE MALEATE
(Antihistamine)

DEXTROMETHORPHAN HBr
(Cough Suppressant)

Relieves:

• Cough Up to 8 Hours
• Runny Nose

Alcohol-Free

fruit punchflavor

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

ROBITUSSIN   DAY AND NIGHT COUGH RELIEF VALUE PACK
dextromethorphan hydrobromide, guaifenesin, chlorpheniramine maleate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-2099

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-2099-01	1 in 1 CARTON; Type 0: Not a Combination Product	05/12/2020

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

Part 1 of 2

CHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM 
dextromethorphan hydrobromide and guaifenesin liquid

Product Information
Item Code (Source)	NDC: 0031-8702
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
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)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8702-13	1 in 1 CARTON
1		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 Drug	M012	05/12/2020

Part 2 of 2

CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM 
chlorpheniramine maleate, dextromethorphan hydrobromide solution

Product Information
Item Code (Source)	NDC: 0031-8692
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	FRUIT PUNCH	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8692-13	1 in 1 CARTON
1		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 Drug	M012	07/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/12/2020

Labeler - Haleon US Holdings LLC (079944263)