NIGHT TIME COUGH- 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

Purpose

Cough suppressant

Antihistamine

Uses

temporarily relieves cold symptoms
cough due to minor throat and bronchial irritation
runny nose and sneezing

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 that lasts or as occurs with smoking, 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 sedatives or tranquilizers.

When using this product

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

cough lasts more than 7 days,come back, or is accompanied by fever,rash, or persistent headache

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

do not take more than 4 doses in any 24-hour period
take only as directed
measure only with dosing cup provided. Do not use any other dosing device
mL = milliliter
adults and children 12 years and over: 30 mL every 6 hours
children under 12 years of age: do not use

Other information

each 30 mL contains; sodium 29 mg
store between 20-25ºC (68-77º). Do not refrigerate.

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 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to active ingredients in Vicks'® Nyquil® Cough*

NightTime Cough

all night cough relief

dextromethorphan HBr

doxylamine succinate

relieves

cough
runny nose & sneezing

for ages12 and over

alcohol 10%

cherry flavor

FL OZ (mL)

*This product is not manufactured or distributed by The Proctor & 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.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Product Label

Dextromethorphan HBr 30 mg, Doxylamine Succinate 12.5 mg

READYinCASE NightTime Cough

NIGHT TIME COUGH
dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49580-0499
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49580-0499-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/31/2017	12/31/2025
2	NDC:49580-0499-2	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/31/2017	12/31/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/31/2017	12/31/2025

Labeler - P & L Development, LLC (101896231)

Revised: 5/2023

Document Id: fc40e0fd-6661-4db4-8a58-42c38265781d

Set id: 0083dfb6-9e47-4def-aab2-673f640866eb

Version: 4

Effective Time: 20230524

P & L Development, LLC