Nighttime Cough
- Manufacturer
- AptaPharma Inc.
- Effective date
- 2018-10-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:45:41
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 30 mL)
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
OTC - PURPOSE SECTION
Purpose
Dextromethorphan HBr ..................... Cough suppressant
Doxylamine Succinate ...................... Antihistamine
INDICATIONS & USAGE SECTION
Uses
Temporarily relieves cold symptoms:
• runny nose and sneezing
• cough
WARNINGS SECTION
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. • to make a child sleepy
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have • a sodium restricted diet
• 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 an enlarged prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use • if you are taking
sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product • do not use more than directed
• avoid alcoholic drinks • excitability may occur, especially in
children • marked drowsiness may occur • be careful when driving
amotor vehicle or operating machinery • alcohol, sedatives, and
tranquilizers may increase drowsiness
OTC - STOP USE SECTION
Stop use and ask a doctor if • redness or swelling is
present • cough lasts more than 7 days, comes back, or
occurs with fever, rash, or headache that lasts. These
could be signs of aserious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional
before use.
Keep out of reach of children
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
Directions
• use dose cup
• do not exceed 4 doses per 24 hours
• When using Day Time and Night Time products, carefully
read each label to ensure correct dosing.
- mL= milliliter
| Adults & children 12 years and over | 30 mL every 6 hours |
| Children 4 to under 12 years | Ask a doctor |
| Children under 4 years of age | Do not use |
OTHER SAFETY INFORMATION
Other information
• each 30 mL contains: sodium 10 mg
• store at room temperature
• dosing cup provided
INACTIVE INGREDIENT SECTION
Inactive ingredients
Anhydrous citric acid, flavor, purified water, sodium benzoate, sucrose
OTC - QUESTIONS SECTION
Ouestions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Principal Display Panel
CVS
HealthTM
Compare to the
active ingredients in
Vicks® NyQuil® Cough*
Nighttime
Cough
Free of alcohol, dyes &
artificial sweeteners
DEXTROMETHORPHAN HBr
Cough suppressant
DOXYLAMINE SUCCINATE
Antihistamine
Relieves:
• Cough
• Sneezing
• Runny nose
Cherry Flavor
ForAges
12 & Over
8 FL OZ (237 mL)
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences
*This product is not manufactured or distributed by Proctor
& Gamble, owner of the registered trademarks Vicks®
and NyQuil®.
Lot:
Exp:
LR-106 #442933
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-34874
√CVS Quality
Moneu Back Guarantee
Nighttime Cough Relief by CVS Pharmacy, Inc.
res
Products#
Every source-derived product name is available through these pages.
- Nighttime Cough
- DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- ANHYDROUS CITRIC ACID
- WATER
- SODIUM BENZOATE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76281-308 | 76281-308-26 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCROSE | C151H8M554 | IACT |
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 |
|---|---|---|---|---|---|---|
| 76abb7f4-ea84-49b2-8a27-8d7b308c3b39 | a10c4c14-d4e9-4e5f-bd07-3c5597c051be | 2022-12-16 | Warnings | a10c4c14-d4e9-4e5f-bd07-3c5597c051be |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
