NDC | 55319-345-10 |
Set ID | df4e8de6-d9de-4615-be73-46903e92a90c |
Category | HUMAN OTC DRUG LABEL |
Packager | Family Dollar (FAMILY WELLNESS) |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each 30 mL)
- Purpose
- Uses
-
Warnings
Do not use
- to make a child sleepy
- 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.
Ask a doctor before use if you have
- a sodium-restricted diet
- asthma
- emphysema
- glaucoma
- chronic bronchitis
- excessive phlegm (mucus)
- breathing problems
- persistent or chronic cough
- cough associated with smoking
- trouble urinating due to enlarged prostate gland
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 a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
-
Directions
- take only as recommended
- do not exceed 4 doses per 24 hours
- use dosage cup provided
- mL = milliliter
age dose adults & children 12 years & over 30 mL every 6 hours children 4 to 11 years do not use unless directed by a doctor children under 4 years do not use - When using DayTime and Nighttime products,carefully read each label to ensure correct dosing
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENTS OF VICKS® NYQUIL® COUGH*
NightTime Cough
All Night Cough Relief
Dextromethorphan HBr- Cough Suppressant,
Doxylamine Succinate- Antihistamine
CHERRY
ALCOHOL 10 %
FL OZ (mL)
*This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Vicks® NyQuil® Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
Failure to follow these warnings could result in serious consequences.
DISTRIBUTED BY:
FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD,
MATTHEWS, NC 28105 USA
VISIT FAMILYDOLLAR.COM
- Product Label
-
INGREDIENTS AND APPEARANCE
NIGHT TIME COUGH
dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-345 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 ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-345-10 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/31/2016 04/26/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/31/2016 04/26/2024 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)