Label: NIGHT TIME COUGH- dextromethorphan hydrobromide, doxylamine succinate liquid
- NDC Code(s): 55319-345-10
- Packager: Family Dollar (FAMILY WELLNESS)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 20, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients (in each 30 mL)
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
- 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
Stop use and ask a doctor if
- redness or swelling is present
- new symptoms occur
- fever gets worse or lasts more than 3 days
- pain or cough gets worse or lasts more than 7 days
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
- 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*
All Night Cough Relief
Dextromethorphan HBr- Cough Suppressant,
Doxylamine Succinate- Antihistamine
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.
FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD,
MATTHEWS, NC 28105 USA
- Product Label
INGREDIENTS AND APPEARANCE
NIGHT TIME COUGH
dextromethorphan hydrobromide, doxylamine succinate liquid
Product 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)