COLD AND FLU NIGHTTIME RELIEF- acetaminophen, doxylamine succinate, and dextromethorphan hbr solution

COLD and FLU Nighttime Relief by

Drug Labeling and Warnings

COLD and FLU Nighttime Relief by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

PURPOSE

Active ingredients (in each 30 mL dose cup)                   Purpose

Acetaminophen, USP 650 mg                                       Pain reliever/fever reducer
Dextromethorphan HBr, USP 30 mg                                       Cough suppressant
Doxylamine succinate, USP 12.5 mg                                                Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• fever
• runny nose and sneezing

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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.
• to make a child sleep

Ask a doctor before use if you have

• liver disease
• glaucoma
• 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
• trouble urinating due to enlarged prostate gland
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

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

• pain or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• 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.

Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as directed – see Overdose warning
• use dose cup or tablespoon (TBSP)
• do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours
• mL = milliliter; TBSP = tablespoon

• adults & children 12 years & over: 30 mL (2 TBSP) every 6 hours
• children 4 to under 12 years: ask a doctor
• children under 4 years: do not use

• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information

• each 30 mL dose cup contains: potassium 5 mg, sodium 38 mg
• store at 20° to 25°C (68° to 77°F)

Inactive ingredients

acesulfame potassium, alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavors, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or Comments?

1-855-274-4122

Distributed by:
Pharmacy Value Alliance LLC
407 East Lancaster Avenue,
Wayne, PA 19087
www.emersongroup.com
MADE IN USA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)

Compare to the active ingredients
in Vicks®  NyQuil® Cold & Flu*

Premier Value®

COLD & FLU
Nighttime Relief

650 mg - Acetaminophen USP (Pain Reliever/Fever Reducer)
12.5 mg - Doxylamine Succinate USP (Antihistamine)
30 mg - Dextromethorphan HBr USP (Cough Suppressant)

• Aches, Fever & Sore Throat
• Sneezing, Runny Nose
• Cough

Alcohol 10%

Cherry Flavor
8 FL OZ (237 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (355 mL Bottle)

Compare to the active ingredients
in Vicks® NyQuil® Cold & Flu*

Premier Value®

COLD & FLU
Nighttime Relief

650 mg - Acetaminophen USP (Pain Reliever/Fever Reducer)
12.5 mg - Doxylamine Succinate USP (Antihistamine)
30 mg - Dextromethorphan HBr USP (Cough Suppressant)

• Aches, Fever & Sore Throat
• Sneezing, Runny Nose
• Cough

Alcohol 10%

Cherry Flavor
12 FL OZ (355 mL)



 

INGREDIENTS AND APPEARANCE

COLD AND FLU NIGHTTIME RELIEF 
acetaminophen, doxylamine succinate, and dextromethorphan hbr solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-709
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CHERRY (UNII: BUC5I9595W)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY, MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-709-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/27/2015

COLD AND FLU NIGHTTIME RELIEF 
acetaminophen, doxylamine succinate, and dextromethorphan hbr solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-707
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CHERRY (UNII: BUC5I9595W)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY, MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-707-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/27/2015

Labeler - Chain Drug Consortium, LLC (101668460)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(68016-707, 68016-709)