DAYTIME NIGHTTIME ULTRA CONCENTRATED- daytime - acetaminophen, dextromethorphan hbr, phenylephrine hcl and nighttime - acetaminophen, dextromethorphan hbr, doxylamine succinate kit

Daytime Nighttime by

Drug Labeling and Warnings

Daytime Nighttime by is a Otc medication manufactured, distributed, or labeled by KROGER COMPANY, TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Daytime Ultra Concentrated Cold & Flu

Active ingredient (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

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 hours, which is the maximum daily amount for this product
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, 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.

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 such 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 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.

OVERDOSAGE

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

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 no greater than 25°C

Inactive ingredients

FD&C yellow no. 6 Al. lake, gelatin, glycerin, mica, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

Call 1-800-632-6900

Drug Facts

Nighttime Ultra Concentrated Cold & Flu

Active ingredient (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

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 hours, which is the maximum daily amount for this product
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, 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.

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, 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.

SPL UNCLASSIFIED SECTION

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

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 no greater than 25°C

Inactive ingredients

D&C yellow no. 10 Al. lake, FD&C blue no. 1 Al. lake, gelatin, glycerin, mica, polyethylene glycol 400, povidone, propylene glycol,
purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

Call 1-800-632-6900

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAYTIME NIGHTTIME  ULTRA CONCENTRATED
daytime - acetaminophen, dextromethorphan hbr, phenylephrine hcl and nighttime - acetaminophen, dextromethorphan hbr, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41226-778

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41226-778-83	1 in 1 CARTON	04/30/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	48
Part 2	1 BOTTLE	48

Part 1 of 2

DAYTIME ULTRA CONCENTRATED COLD AND FLU 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Product Information
Item Code (Source)	NDC: 41226-777
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
SORBITAN (UNII: 6O92ICV9RU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
MICA (UNII: V8A1AW0880)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	151
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		48 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 Drug	M012	04/30/2025

Part 2 of 2

NIGHTTIME ULTRA CONCENTRATED COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Product Information
Item Code (Source)	NDC: 41226-756
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
SORBITAN (UNII: 6O92ICV9RU)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
SORBITOL (UNII: 506T60A25R)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
SHELLAC (UNII: 46N107B71O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	152
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		48 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 Drug	M012	04/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/30/2025

Labeler - KROGER COMPANY (006999528)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(41226-777, 41226-756, 41226-778)