NIGHTTIME COUGH ALL NIGHT COUGH RELIEF- dextromethorphan hydrobromide, doxylamine succinate liquid 
P & L Development, LLC

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

Purposes

Cough suppressant

Antihistamine

Uses

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.

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem or chronic cough thats lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedative or tranquilizers.

When using this product

  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant breast-feeding,

ask a health professiuonal before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Directions

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

Principal Display Panel

Compare to active ingredients in Vicks® NyQuil® Cough*

Night Time

Cough

all night cough relief

Dextromethorphan HBr

Doxylamine succinate

Relieves:

for ages 12 and over

nighttime relief

alcohol 10%

FL OZ (mL)

cherry flavor

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

Product Label

Dextromethorphan HBr 30 mg, Doxylamine succinate 12.5 mg

READYINCASE Nighttime Cough Cherry Flavor

NIGHTTIME COUGH  ALL NIGHT COUGH RELIEF
dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0345
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49580-0345-1296 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/201412/31/2024
2NDC:49580-0345-6177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/201412/31/2024
3NDC:49580-0345-2355 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/201412/31/2024
4NDC:49580-0345-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/201412/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/201412/31/2024
Labeler - P & L Development, LLC (101896231)

Revised: 5/2023
Document Id: b40ddc2e-2388-4b41-bd53-13b6fd7f99d4
Set id: 51dbf501-eb6f-4aab-9e6f-68b92e0c58db
Version: 7
Effective Time: 20230524
 
P & L Development, LLC