NIGHT TIME COUGH- dextromethorphan hydrobromide, doxylamine succinate liquid 
Safeway, Inc.

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.

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Drug Facts

Active ingredients (in each 30 mL)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Cough suppressant

Antihistamine

Uses

temporarily relieves cold symptoms

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
  • excessive phlegm (mucus)
  • breathing problems
  • chronic bronchitis
  • persistent or chronic cough
  • cough associated with smoking
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

agedose 
 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

Other information

Inactive ingredients

alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

 Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

NightTime Cough Relief 

Dextromethorphan HBr- Cough Suppressant

Doxylamine Succinate- Antihistamine

Compare to Vicks® NyQuil® Cough active ingredient* 

10% ALCOHOL

AGES 12 & OVER

FL OZ (mL)

CHERRY FLAVOR

*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.

DISTREBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

Product Label

Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg

Signature Care Nighttime Cough Relief

NIGHT TIME COUGH 
dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-345
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-345-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201505/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/30/201505/31/2024
Labeler - Safeway, Inc. (009137209)

Revised: 11/2021
Document Id: edafb3d0-9498-40ee-8361-2ebe828cad27
Set id: 50330d79-b35d-468e-8cb6-a1e4565ae813
Version: 3
Effective Time: 20211105
 
Safeway, Inc.