NIGHTTIME COUGH- dextromethorphan hbr, doxylamine succinate liquid

Nighttime Cough by

Drug Labeling and Warnings

Nighttime Cough by is a Otc medication manufactured, distributed, or labeled by AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 30 mL)
Dextromethorphan HBr              30 mg
Doxylamine Succinate            12.5 mg

PURPOSE

Purpose
Dextromethorphan HBr ..................... Cough suppressant
Doxylamine Succinate ...................... Antihistamine

INDICATIONS & USAGE

Uses
Temporarily relieves cold symptoms:
runny nose and sneezing
cough

WARNINGS

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

ASK DOCTOR

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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking
sedatives or tranquilizers

WHEN USING

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

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

Inactive ingredients
Anhydrous citric acid, flavor, purified water, sodium benzoate, sucrose

QUESTIONS

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

INGREDIENTS AND APPEARANCE

NIGHTTIME COUGH 
dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-308
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-308-26	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2018

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-308)