Indications and uses
temporarily relieves cold symptoms cough due to minor throat and bronchial irritation runny nose and sneezing
Night Time Cough
- Manufacturer
- Family Dollar (FAMILY WELLNESS)
- Effective date
- 2023-02-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:36:49
Label at a glance#
ProductNight Time Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections
Dosage and administration
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 take only as directed mL = milliliter adults and children 12 years and over: 30 mL every 6 hours children under 12 years of age: do not use
Storage and handling
each 30 mL contains ; sodium 29 mg store between 20-25ºC (68-77ºF). Do not refrigerate.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 30 mL)
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Purpose
Cough suppressant
Antihistamine
Uses
- temporarily relieves cold symptoms
- cough due to minor throat and bronchial irritation
- runny nose and sneezing
Warnings
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
- glaucoma
- 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
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
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 sign of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- 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
- take only as directed
- 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
- each 30 mL contains; sodium 29 mg
- store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive ingredients
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?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL® COUGH*
NightTime Cough
COUGH SUPPRESSANT
Dextromethorphan HBr - Cough Suppressant,
Doxylamine Succinate - Antihistamine
RELIEVES
- sneezing & runny nose
- cough
For ages 12 years and over
Nighttime Relief
Alcohol 10%
CHERRY
FL OZ (mL)
*This product is not manufactured or distributed by The Proctor & Gamble Company. Vicks® and NyQuil® are registered trademarks of the Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
Product Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55319-499-12 | 2023-02-11 | C162847 | 48780-1 | d6a99b39-511f-a426-e053-dadaa90af4c2 | Drug Facts |
| 55319-499-12 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-511f-a426-e053-dadaa90af4c2 | Drug Facts |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- 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#
| Product NDC | Package NDC |
|---|---|
| 55319-499 | 55319-499-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| c621329f-e125-4271-ae8c-3d64de333188 | 2f822595-796e-402d-bb1e-a497fa53c435 | 2023-02-11 | Warnings | c621329f-e125-4271-ae8c-3d64de333188 2f822595-796e-402d-bb1e-a497fa53c435 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.