DAYTIME AND NIGHTTIME COUGH RELIEF- dextromethorphan hbr, guaifenesin, dextromethorphan hbr, doxylamine succinate kit

Daytime and Nighttime Cough Relief by

Drug Labeling and Warnings

Daytime and Nighttime Cough Relief by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc., Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts - Day Time

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 mg

Drug Facts - Night Time

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 30 mg
Doxylamine Succinate, USP 12.5 mg

Purposes - Day Time

Cough suppressant
Expectorant

Purposes - Night Time

Cough suppressant

Antihistamine

Uses - Day Time

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Uses - Night Time

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat
• controls the impulse to cough to help you sleep

Warnings - Day Time

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.

Warnings - Night Time

Do not use

• to sedate a child or 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 - Day Time

• cough that occurs with too much phlegm(mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor before use if you have - Night Time

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

Ask a doctor or pharmacist before use if you are - Night Time

taking sedatives or tranquilizers

When using this product - Night Time

• do not use more than directed
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if - Day Time

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.

Stop use and ask a doctor if - Night Time

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 or breast-feeding, - Day Time

ask a health professional before use.

If pregnant or breast-feeding, - Night Time

ask a health professional before use.

Keep out of reach of children. - Day Time

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

Keep out of reach of children. - Night Time

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

Directions - Day Time

• shake well before using
• do not take more than 6 doses (12 tsp) in any 24-hour period
• measure only with dosing cup provided
• keep dosing cup with product
• mL = milliliter
• this adult product is not intended for use in children under 12 years of age

• Age: Dose
• adults and children 12 years and over: 10 mL every 4 hours
• children under 12 years: do not use

Directions - Night Time

• measure only with dosing cup provided
• keep dosing cup with product
• mL = milliliter
• do not take more than 4 doses (8 tsp) in any 24-hour period
• this adult product is not intended for use in children under 12 years of age
• shake well before using

• age: dose
• adults and children 12 years and over: 10 mL every 6 hours
• children under 12 years: do not use

Other information - Day Time

• each 10 mL contains: sodium 8 mg
• store at 20-25°C (68-77°F). Do not refrigerate
• alcohol-free

Other information - Night Time

• each 10 mL contains: sodium 7 mg
• store at 20-25°C (68-77°F).
• alcohol-free

Inactive ingredients - Day Time

anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Inactive ingredients - Night Time

anhydrous citric acid, FD&C red # 40, flavors, glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum

Questions or comments?

1-855-274-4122

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2016 CVS/pharmacy
CVS.com     1-800-SHOP CVS
V-32402

CVS® Quality
Money Back Guarantee

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (236 mL Bottle)

Compare to the active ingredients in Adult
Robitussin® Peak Cold Maximum Strength Cough + Chest Congestion DM*

MAXIMUM STRENGTH
FOR MUCUS RELIEF
Non-Drowsy
Tussin DM
DEXTROMETHORPHAN HBr, 20mg
Cough suppressant
 

GUAIFENESIN, USP 400 mg
Expectorant

Adult Cough &
Chest Congestion
Relieves:

• Cough
• Chest congestion/mucus

Alcohol free

Cherry Flavor
Liquid

For Ages 12 & Over

Compare to the active ingredients in Adult Robitussin® Maximum
Strength Nighttime Cough DM*

MAXIMUM STRENGTH
Nighttime
Tussin DM

DEXTROMETHORPHAN HBr, 30 mg
Cough suppressant

DOXYLAMINE SUCCINATE 12.5 mg
Antihistamine

Adult Cough
& Antihistamine

Relieves:

• Cough
• Itchy throat
• Runny nose

Alcohol free

Pineapple Flavor
Liquid

For Ages 12 & Over

4 FL OZ (118 mL) + 4 FL OZ (118 mL)
TOTAL 8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

DAYTIME AND NIGHTTIME COUGH RELIEF 
dextromethorphan hbr, guaifenesin, dextromethorphan hbr, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-009

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-009-20	1 in 1 CARTON; Type 0: Not a Combination Product	05/02/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118 mL
Part 2	1 BOTTLE	118 mL

Part 1 of 2

DAYTIME COUGH RELIEF 
dextromethorphan hbr, guaifenesin liquid

Product Information
Item Code (Source)	NDC: 69842-007
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CHERRY (UNII: BUC5I9595W)
VANILLA (UNII: Q74T35078H)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
LEVOMENTHOL (UNII: BZ1R15MTK7)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED (a red colored liquid)	Score
Shape		Size
Flavor	CHERRY, VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-007-24	1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/02/2016

Part 2 of 2

NIGHTTIME COUGH RELIEF 
dextromethorphan hbr, doxylamine succinate liquid

Product Information
Item Code (Source)	NDC: 69842-013
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 10 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ORANGE (UNII: 5EVU04N5QU)
PINEAPPLE (UNII: 2A88ZO081O)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
LEVOMENTHOL (UNII: BZ1R15MTK7)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED (a clear red colored liquid)	Score
Shape		Size
Flavor	MENTHOL, ORANGE, PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-013-20	1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/02/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/02/2016

Labeler - CVS Pharmacy, Inc. (062312574)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(69842-009)