FDA Label for Nighttime Cough Relief Cherry
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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.