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#

ProductNighttime Cough
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)
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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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
                Age                                                                          Dose
 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

PACKAGE LABEL.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

308-26 Label308-26 Label

                                                    Nighttime Cough Relief by CVS Pharmacy, Inc.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-30876281-308-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML · Source PDF

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
76abb7f4-ea84-49b2-8a27-8d7b308c3b39a10c4c14-d4e9-4e5f-bd07-3c5597c051be2022-12-16WarningsExact identifier
spl set id: a10c4c14-d4e9-4e5f-bd07-3c5597c051be

Reported adverse events (FAERS/openFDA)#

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