Indications and uses
temporarily relieves cold symptoms cough due to minor throat and bronchial irritation runny nose and sneezing
Cough Relief
- Manufacturer
- Freds Inc
- Effective date
- 2021-10-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:31:47
Label at a glance#
ProductCough Relief Nighttime
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections
Dosage and administration
do not take more than 4 doses in any 24-hours 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#
Websitewww.fredsinc.com
www.fredsinc.com
www.fredsinc.comLabel contents#
Full prescribing information#
Active ingredients (in each 30 mL)
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Purposes
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 phligm (mucus)
- breathing problems 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
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
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 signs 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-hours 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 PST
Principal Display Panel
NIGHTTIME
Cough Relief
Each dose (per 30 mL) of oral solution contains:
30 mg-Dextromethorphan HBr- Cough Suppressant
12.5 mg-Doxylamine Succinate- Antihistamine
- Sneezing, runny nose
- cough
Compare to the active ingredients in Vicks® NyQuil® Cough*
Alcohol 10% • Ages 12 +
FL OZ (mL)
CHERRY FLAVOR
*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: fred's
4300 NEW GETWELL RD., MEMPHIS, TN 38118
Product Label
Products#
Every source-derived product name is available through these pages.
- Cough Relief Nighttime
- 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 |
|---|---|
| 55315-499 | 55315-499-12 |
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 |
|---|---|---|---|---|---|---|
| a2747420-28f8-486d-95d8-409c3b0afe6b | 70a8aeaf-528b-4808-88c8-794bc7ccbc0d | 2021-10-19 | Warnings | a2747420-28f8-486d-95d8-409c3b0afe6b 70a8aeaf-528b-4808-88c8-794bc7ccbc0d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.