Adult Tussin Maximum Strength Nighttime Cough DM

Manufacturer
Aurohealth LLC
Effective date
2019-11-28
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:56:06

Label at a glance#

ProductAdult Tussin Maximum Strength Nighttime Cough DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure16 sections

Indications and uses

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

Dosage and administration

measure only with dosing cup provided keep dosing cup with product mL = milliliter do not take more than 4 doses (8 tsp) in any 24-hour period this adult product is not intended for use in children under 12 years of age shake well before using age dose adults and children 12 years and over 10 mL every 6 hours children under 12 years do not use

Storage and handling

each 10 mL contains: sodium 7 mg store at 20-25°C (68-77°F) alcohol-free

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 30 mg
Doxylamine Succinate, USP 12.5 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant
Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • 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

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • do not take more than 4 doses (8 tsp) in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
  • shake well before using

age
dose
adults and children 12 years and over
10 mL every 6 hours
children under 12 years
do not use


Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains: sodium 7 mg
  • store at 20-25°C (68-77°F)
  • alcohol-free

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.

Questions or Comments

OTC - QUESTIONS SECTION

1-855-274-4122

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

SPL UNCLASSIFIED SECTION

NDC 58602-512-24

PrimaryHealth

COMPARE TO Adult Robitussin®
Maximum Strength Nighttime
Cough DM Active Ingredients*

Adult
Tussin

MAXIMUM STRENGTH
Nighttime Cough DM

Each 10 mL dose of oral
solution contains:
30 mg - Dextromethorphan HBr, USP
(Cough Suppressant)
12.5 mg - Doxylamine Succinate, USP
(Antihistamine)

Relieves:
• Cough
• Itchy Throat
• Runny Nose
For Ages 12 & Over
Max Strength
Nighttime Cough Control

DM
NIGHTTIME
MAX


Pineapple Flavor
4 FL OZ (118 mL)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL CONTAINER - 4 FL OZ (118 mL Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL CONTAINER - 4 FL OZ (118 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-512-24

PrimaryHealth

COMPARE TO
Adult Robitussin®
Maximum Strength Nighttime
Cough DM Active Ingredients*

Adult
Tussin
MAXIMUM STRENGTH
Nighttime Cough DM

Each 10 mL dose of oral
solution contains:
30 mg - Dextromethorphan HBr, USP
(Cough Suppressant)
12.5 mg - Doxylamine Succinate, USP
(Antihistamine)

Relieves:
• Cough
• Itchy Throat
• Runny Nose
For Ages 12 & Over
Max Strength
Nighttime Cough Control

DM
NIGHTTIME
MAX

Pineapple Flavor 
4 FL OZ (118mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL CONTAINER CARTON - 4 FL OZ (118 mL Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL CONTAINER CARTON - 4 FL OZ (118 mL Bottle)

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-51258602-512-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2c0f2c91-f9a9-47b8-805a-f5eb2aa40cb06e2f7caa-e150-4c93-a60f-3f0964e9e3622020-11-27WarningsExact identifier
spl set id: 6e2f7caa-e150-4c93-a60f-3f0964e9e362

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.