NDC | 68016-238-08 |
Set ID | f7323a2b-1777-4d8f-a2ca-328bf2018d97 |
Category | HUMAN OTC DRUG LABEL |
Packager | Pharmacy Value Alliance, LLC |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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 DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- 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 hourschildren 4 to under 12 years ask a doctor
children under 4 years do not use
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
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 NoseCherry Flavor
8 FL OZ (237 mL)
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEEDDO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequencesQuestions? Call weekdays 1-877-798-5944.
*This product is not manufactured or distributed by
Proctor & Gamble owner of the registered
trademark Vicks® NyQuil® CoughDISTRIBUTED BY:
PHARMACY VALUE ALLIANCE, LLC
407 EAST LANCASTER AVENUE,
WAYNEPA 19087INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEEDIf 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 01Product 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 liquidProduct 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)