ROBITUSSIN DAY AND NIGHT COUGH RELIEF DM MAX- dextromethorphan hydrobromide, 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 20 mL) – Robitussin Maximum Strength Cough+Chest Congestion DM

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Purposes – Robitussin Maximum Strength Cough+Chest Congestion DM

Cough suppressant

Expectorant

Uses – Robitussin Maximum Strength 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 – Robitussin Maximum Strength 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 processional before use.

Keep out of reach of children.

Directions – Robitussin Maximum Strength 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

this adult product is not intended for use in children under 12 years of age

• age:

  dose

• adults and children 12 years and over:

  20 mL every 4 hours

• children under 12 years:

  do not use

Other information – Robitussin Maximum Strength Cough+Chest Congestion DM

• ▪ each 20 mL contains: sodium 13 mg
• ▪ store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients – Robitussin Maximum Strength Cough+Chest Congestion DM

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

Questions or comments? – Robitussin Maximum Strength Cough+Chest Congestion DM

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

Active ingredients (in each 20 mL) – Robitussin Maximum Strength Nighttime Cough DM

Dextromethorphan HBr, USP 30 mg

Doxylamine succinate, USP 12.5 mg

Purposes – Robitussin Maximum Strength Nighttime Cough DM

Cough suppressant

Antihistamine

Uses – Robitussin Maximum Strength 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 – Robitussin Maximum Strength 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 a 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

Directions – Robitussin Maximum Strength 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
• this adult product is not intended for use in children under 12 years of age

• age:

  dose

• adults and children 12 years and over:

  20 mL every 6 hours

• children under 12 years:

  do not use

Other information – Robitussin Maximum Strength Nighttime Cough DM

• ▪ each 20 mL contains: sodium 14 mg
• ▪ store at 20-25°C (68-77°F)

Inactive ingredients – Robitussin Maximum Strength Nighttime Cough DM

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

Questions or comments? – Robitussin Maximum Strength Nighttime Cough DM

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

Additional information – Robitussin Maximum Strength Day/Night Combination Package

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.

4 oz 8 oz Maximum Strength Cough+Chest Congestion DM

8 oz Maximum Strength Nighttime Cough DM

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

STRONG SOOTHING ACTION and fast, powerful cough relief

PARENTS: Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel – Robitussin Maximum Strength Cough+Chest Congestion DM

ADULT

Robitussin

MAXIMUM STRENGTH

Cough+Chest Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

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

FAST, EFFECTIVE cough relief

DM MAX

For Ages 12 & Over

4 FL OZ (118 mL)

Principal Display Panel – Robitussin Maximum Strength Nighttime Cough DM

ADULT

Robitussin

MAXIMUM STRENGTH

Nighttime Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

Controls Cough

Relieves Runny Nose & Sneezing

FAST, EFFECTIVE cough relief

DM NIGHTTIME MAX

For Ages 12 & Over

8 FL OZ (237 mL)

Principal Display Panel – Robitussin Maximum Strength Day/Night Combination Package

DAY&NIGHT COUGH RELIEF

DM MAX

ADULT

INCLUDES TWO 8oz AND ONE 4oz

Robitussin

MAXIMUM STRENGTH

COUGH+CHEST CONGESTION DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

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

FAST, EFFECTIVE cough relief

DM MAX

2 BOTTLES

1-8 FL OZ (237 mL) / 1-4 FL OZ (118 mL)

MAXIMUM STRENGTH

Nighttime Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

• ✓ Controls Cough
• ✓ Relieves Runny Nose & Sneezing

FAST, EFFECTIVE cough relief

DM NIGHTTIME MAX

1 BOTTLE

8 FL OZ (237 mL)

For Ages 12 & Over

3 BOTTLES – 20 FL OZ (591 mL) TOTAL

INGREDIENTS AND APPEARANCE

ROBITUSSIN  DAY AND NIGHT COUGH RELIEF DM MAX
dextromethorphan hydrobromide, guaifenesin, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-2834

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-2834-01	1 in 1 CARTON; Type 0: Not a Combination Product	03/01/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	3 BOTTLE	391 mL
Part 2	1 BOTTLE	237 mL

Part 1 of 2

ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin solution

Product Information
Item Code (Source)	NDC: 0031-8739
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	400 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)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRIACETIN (UNII: XHX3C3X673)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8739-12	1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2	NDC: 0031-8739-18	1 in 1 CARTON
2		237 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	06/01/2016

Part 2 of 2

ROBITUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM 
dextromethorphan hydrobromide, doxylamine succinate solution

Product Information
Item Code (Source)	NDC: 0031-8718
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 20 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 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)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRIACETIN (UNII: XHX3C3X673)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8718-18	1 in 1 CARTON
1		237 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	06/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/01/2021

Labeler - Haleon US Holdings LLC (079944263)