Night Time Cough

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves cold symptoms
• cough due to minor throat and bronchial irritation
• runny nose and sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• 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
• a breathing problem or chronic cough that lasts or as occurs with smoking, chronic bronchitis,or emphysema
• cough that occurs with too much phlegm (mucus)
• trouble urinating due to enlarged prostate gland

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

• avoid alcoholic drinks
• excitability may occur, especially in children
• marked drowsiness may occur
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsiness

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

• do not take more than 4 doses in any 24-hour period
• take only as directed
• keep dosing cup with product
• measure only with dosing cup provided. Do not use any other dosing device
• mL = milliliter
• adults and children 12 years and over: 30 mL every 6 hours
• children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

• each 30 mL contains; sodium 29 mg
• store between 20-25ºC (68-77º). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

 Call 1-877-753-3935  Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NightTime Cough

all night cough relief

dextromethorphan HBr

doxylamine succinate

relieves

• cough
• runny nose & sneezing

for ages12 and over

alcohol 10%

cherry flavor

FL OZ (mL)

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

Distributed by:

PL Developments

513 Old Griffin Road

Piedmont, SC 29673

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

• Night Time Cough
• Dextromethorphan Hydrobromide, Doxylamine Succinate
• DEXTROMETHORPHAN HYDROBROMIDE
• DEXTROMETHORPHAN
• DOXYLAMINE SUCCINATE
• DOXYLAMINE
• ALCOHOL
• ANHYDROUS CITRIC ACID
• FD&C BLUE NO. 1
• FD&C RED NO. 40
• HIGH FRUCTOSE CORN SYRUP
• POLYETHYLENE GLYCOL, UNSPECIFIED
• PROPYLENE GLYCOL
• WATER
• SACCHARIN SODIUM
• TRISODIUM CITRATE DIHYDRATE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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.

Reported adverse events (FAERS/openFDA)#

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