NDC | 76281-308-26 |
Set ID | a10c4c14-d4e9-4e5f-bd07-3c5597c051be |
Category | HUMAN OTC DRUG LABEL |
Packager | AptaPharma Inc. |
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 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 DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- 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
Age Dose 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
- INACTIVE INGREDIENT
- QUESTIONS
-
Principal Display Panel
CVS
HealthTMCompare to the
active ingredients in
Vicks® NyQuil® Cough*Nighttime
CoughFree of alcohol, dyes &
artificial sweetenersDEXTROMETHORPHAN HBr
Cough suppressantDOXYLAMINE SUCCINATE
AntihistamineRelieves:
• Cough
• Sneezing
• Runny noseCherry Flavor
ForAges
12 & Over8 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 liquidProduct 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)