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#

ProductNighttime Cough Relief Cherry
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure16 sections

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.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

238-08 8 OZ238-08 8 OZ

                                          Premier Value® Nighttime Cough Relief Cherry Flavor

238-08 8 OZ238-08 8 OZ

res

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-23868016-238-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
433afbe0-f399-4a7e-9f0c-36412ddc91b6f7323a2b-1777-4d8f-a2ca-328bf2018d972024-12-29WarningsExact identifier
spl set id: f7323a2b-1777-4d8f-a2ca-328bf2018d97

Reported adverse events (FAERS/openFDA)#

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