COLD AND FLU DAYTIME/NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate kit

Cold and Flu Daytime/Nighttime by

Drug Labeling and Warnings

Cold and Flu Daytime/Nighttime by is a Otc medication manufactured, distributed, or labeled by Kroger Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NightTime COLD & FLU

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each Softgel)	Purpose
Acetaminophen 325 mg	Pain reliever / Fever reducer
Dextromethorphan HBr 15 mg	Cough suppressant
Doxylamine succinate 6.25 mg	Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 8 softgels in 24 hrs, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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

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, & 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 directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

• take only as directed - see Overdose warning
• do not exceed 8 softgels per 24 hrs

• adults & children 12 yrs & over: 2 softgels with water every 6 hrs
• children 4 to under 12 yrs: ask a doctor
• children under 4 yrs: do not use

Other information

• store at room temperature between 20-25 °C (68-77 °F)

Inactive ingredients

FD&C Blue #1, FD&C Yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments

1-800-632-6900

SPL UNCLASSIFIED SECTION

DayTime COLD & FLU

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each Softgel)	Purpose
Acetaminophen 325 mg	Pain reliever / Fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 8 softgels in 24 hrs, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily 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.

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• pain, nasal congestion or cough get worse or last 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 directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

• take only as directed - see Overdose warning
• do not exceed 8 softgels per 24 hrs

• adults & children 12 yrs & over: 2 softgels with water every 4 hrs
• children 4 to under 12 yrs: ask a doctor
• children under 4 yrs: do not use

Other information

• store at room temperature between 20-25 °C (68-77 °F)

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments

1-800-632-6900

PRINCIPAL DISPLAY PANEL - Kit Carton

*Compare to active ingredients in Vicks® Dayquil™ and Vicks® Nyquil™ Cold & Flu Liquicaps™

NDC: 30142-620-48

COLD & FLU

DayTime

Multi-Symptom Relief

Pain Reliever
Fever Reducer
Cough Suppressant
Nasal Decongestant

Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg

32
SOFTGELS

COLD & FLU

NightTime

Multi-Symptom Relief

Pain Reliever
Fever Reducer
Cough Suppressant
Antihistamine

Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg

16
SOFTGELS

INGREDIENTS AND APPEARANCE

COLD AND FLU DAYTIME/NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-754

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-754-12	4 in 1 CARTON	05/01/2021
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1		8
Part 2		4

Part 1 of 2

COLD AND FLU DAYTIME 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
Gelatin, Unspecified (UNII: 2G86QN327L)
Glycerin (UNII: PDC6A3C0OX)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
Povidone, Unspecified (UNII: FZ989GH94E)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	786
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/01/2021

Part 2 of 2

COLD AND FLU NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg
Doxylamine Succinate (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	Doxylamine Succinate	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C Blue NO. 1 (UNII: H3R47K3TBD)
D&C Yellow NO. 10 (UNII: 35SW5USQ3G)
Gelatin, Unspecified (UNII: 2G86QN327L)
Glycerin (UNII: PDC6A3C0OX)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
Povidone, Unspecified (UNII: FZ989GH94E)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	787
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/01/2021

Labeler - Kroger Company (006999528)