NIGHTTIME COUGH ALL NIGHT COUGH RELIEF- dextromethorphan hydrobromide, doxylamine succinate liquid

Nighttime Cough by

Drug Labeling and Warnings

Nighttime Cough by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 30 mL)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purposes

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 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

• keep dosing cup with product
• 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 (68-77ºF). 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

Principal Display Panel

Compare to active ingredients in Vicks® NyQuil® Cough*

Night Time

Cough

all night cough relief

Dextromethorphan HBr

Doxylamine succinate

Relieves:

• cough
• runny nose
• sneezing

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

READYINCASE Nighttime Cough Cherry Flavor

INGREDIENTS AND APPEARANCE

NIGHTTIME COUGH  ALL NIGHT COUGH RELIEF
dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49580-0345
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
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
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49580-0345-1	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2014
2	NDC: 49580-0345-2	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2014
3	NDC: 49580-0345-4	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2014
4	NDC: 49580-0345-6	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/31/2014

Labeler - P & L Development, LLC (101896231)