TopCare Tussin DM

Manufacturer
Topco Associates LLC
Effective date
2018-12-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:43:55

Label at a glance#

ProductTopCare Tussin DM Nighttime Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure15 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 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 10 mL every 6 hours children under 12 years do not use

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 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
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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 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

10 mL

every 6 hours

children under 12 years

do not use

Other information

SPL UNCLASSIFIED SECTION

  • each 10 mL contains: sodium 8 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FOR ADULTS

For Ages 12 & Over

Tussin DM

Nighttime Max

COUGH SUPPRESSANT (Dextromethorphan HBr)

ANTIHISTAMINE (Doxylamine Succinate)

Nighttime Cough DM

Maximum Strength

Relieves:

Cough

Itchy Throat

Runny Nose

COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH NIGHTTIME COUGH DM active ingredients

4 FL OZ (118 mL)

TopCare Tussin DM image
TopCare Tussin DM image

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-51136800-511-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
5213ea6d-8319-46f1-918c-2bab90824d81cf15bc0f-bed8-4b0a-aaaf-b7f8fc32e1ba2020-12-16WarningsExact identifier
spl set id: cf15bc0f-bed8-4b0a-aaaf-b7f8fc32e1ba

Reported adverse events (FAERS/openFDA)#

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