FDA Label for Nighttime Cough Relief Cherry

View Indications, Usage & Precautions

Nighttime Cough Relief Cherry Product Label

The following document was submitted to the FDA by the labeler of this product Pharmacy Value Alliance, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Active Ingredient



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


Otc - 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


Otc - 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.


Otc - Ask Doctor/Pharmacist



Ask adoctor or pharmacist before use
• if you are taking sedatives or tranquilizers


Otc - 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


Otc - 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.


Otc - 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


Otc - 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


* Please review the disclaimer below.