FDA.reportPublic FDA data

Tussin DM Nighttime Cough

Manufacturer
WinCo Foods, LLC
Effective date
2021-11-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:28:31

Label at a glance#

ProductTussin DM Nighttime Cough Maximum Strength
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 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

this adult product is not intended for use in children under 12 years of age do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter adults and children 12 years and over: 20 mL every 6 hours children under 12 years: do not use

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 30 mg

Doxylamine succinate 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

Warnings

WARNINGS SECTION

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

  • glaucoma 
  • trouble urinating due to an enlarged prostate gland
  • 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this adult product is not intended for use in children under 12 years of age
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
  • adults and children 12 years and over: 20 mL every 6 hours
  • children under 12 years: do not use

Other information

SPL UNCLASSIFIED SECTION

  • each 20 mL contains: sodium 9 mL
  • store between 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethycellulose sodium, FD&C blue #1, 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

Call 1-800-824-1706 Monday-Friday 9AM-5PM MST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredients in Robitussin® Maximum Strength Nighttime Cough DM

MAXIMUM STRENGTH

Tussin DM

Nighttime 

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE / ANTIHISTAMINE

Relieves: Cough, Itchy Throat & Runny Nose

Adult Formula, For Ages 12 Years & Over

Alcohol Free

Dosage cup provided

FL OZ (mL)

*This product is not manufactured or distributed by PFIZER CONSUMER HEALTHCARE, distributors of RONITUSSIN® Maximum Strength Nighttime Cough DM.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

WINCO FOODS, LLC, BOISE, ID 83704

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WINCO FOODS Maximum Strength Nighttime Cough
WINCO FOODS Maximum Strength Nighttime Cough

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67091-33367091-333-18

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
MENTHOLL7T10EIP3AIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT

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
5dd586e9-597d-4055-8abb-29efea2a0196410ddcb2-dde1-45e3-bb35-d3e4ce75c1f52021-11-09WarningsExact identifier
spl id: 5dd586e9-597d-4055-8abb-29efea2a0196
spl set id: 410ddcb2-dde1-45e3-bb35-d3e4ce75c1f5

Reported adverse events (FAERS/openFDA)#

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