Nighttime Cough Relief
- Manufacturer
- Pharmacy Value Alliance, LLC | AptaPharma Inc.
- Effective date
- 2023-12-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:16:31
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 dose cup)
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 aprescription 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 enlarged prostate gland.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask adoctor 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 • cough lasts more than 7 days,
comes back, or occurs with fever, rash, or headache that lasts.
These could be signs of a serious 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 or tablespoon (TBSP)
• do not exceed 4 doses per 24 hours
• When using Day Time and Night Time products, carefully read
each label to ensure correct dosing.
adults & children 12 30 mL (2 TBSP)
years and over every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use
OTHER SAFETY INFORMATION
Other information
• each 30 mL dose cup contains: sodium 45 mg
• store at room temperature
INACTIVE INGREDIENT SECTION
Inactive ingredients citric acid, FD&C Blue No.
1, FD&C Red No. 40, .flavor, glycerin, polyethylene glycol,
propylene glycol, purified water, saccharin sodium,
sodium benzoate, sodium citrate, sucrose
OTC - QUESTIONS SECTION
Ouestions? Call weekdays from 9:30 am to 4:30 pm
EST. 1-877-798-5944.
Principal Display Panel
Premier Value®
COMPARE TO THE ACTIVE
INGREDIENTS IN
VICKS® NYQUIL®* COUGH*
COUGH
Nighttime Cough Relief
Dextromethorphan HBr...... Cough Suppressant
Doxylamine Succinate ......Antihistamine
• Cough
• Sneezing
• Runny Nose
Cherry Flavor
8 FL OZ (237 mL)
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences
Questions? Call weekdays 1-877-798-5944.
*This product is not manufactured or distributed by
Proctor & Gamble owner of the registered
trademark Vicks® NyQuil® Cough
DISTRIBUTED BY:
PHARMACY VALUE ALLIANCE, LLC
407 EAST LANCASTER AVENUE,
WAYNEPA 19087
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
If for any reason you are not satisfied
with this product, please return it to the
store where purchased for a full refund.
LR-039
REV 01
Product Label - Nighttime Cough Relief - 8 OZ Package
Premier Value® Nighttime Cough Relief Cherry Flavor
res
Products#
Every source-derived product name is available through these pages.
- Nighttime Cough Relief Cherry
- DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- ANHYDROUS CITRIC ACID
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SACCHARIN SODIUM
- SODIUM BENZOATE
- SODIUM CITRATE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68016-238 | 68016-238-08 |
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 |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | 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 |
|---|---|---|---|---|---|---|
| 433afbe0-f399-4a7e-9f0c-36412ddc91b6 | f7323a2b-1777-4d8f-a2ca-328bf2018d97 | 2024-12-29 | Warnings | f7323a2b-1777-4d8f-a2ca-328bf2018d97 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
