NIGHTTIME COUGH RELIEF CHERRY- dextromethorphan hbr, doxylamine succinate liquid

Nighttime Cough Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients  (in each 30 mL dose cup)
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 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

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 enlarged prostate gland.

ASK DOCTOR/PHARMACIST

Ask adoctor 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 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.

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 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

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

QUESTIONS

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

INGREDIENTS AND APPEARANCE

NIGHTTIME COUGH RELIEF  CHERRY
dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-238
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-238-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2018

Labeler - Pharmacy Value Alliance, LLC (101668460)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(68016-238)