DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hbr, phenylephrine hcl and 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 H-E-B, TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS - Daytime Cold & Flu

ACTIVE INGREDIENT

Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

PURPOSE

Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

INDICATIONS & USAGE

Uses
temporarily relieves common cold/flu symptoms:
nasal congestion
cough due to minor throat & bronchial irritation
sore throat
headache
minor aches & pains
fever

WARNINGS

Warnings

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

more than 4 doses 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, 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 as occurs with smoking, asthma, chronic bronchitis, 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 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.
In case of overdose, get medical help or contact a Poison Control Center righl away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

• take only as directed
• do not exceed 4 doses per 24 hrs

adults & children 12yrs & 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

Other information

• store at room temperature

INACTIVE INGREDIENT

Inactive ingredients
FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.

QUESTIONS

Questions? Call 1-877-290-4008

DRUG FACTS - Nighttime Cold & Flu

ACTIVE INGREDIENT

Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

PURPOSE

Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine

INDICATIONS & USAGE

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

Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 4 doses 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, 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 prostrate 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
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 breastfeeding, ask a health professional before use.

Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions
take only as directed
do not exceed 4 doses 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

STORAGE AND HANDLING

Other information
store at room temperature

INACTIVE INGREDIENT

Inactive ingredients FD&C blue #1, D&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.

QUESTIONS

Questions? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAYTIME NIGHTTIME 
acetaminophen, dextromethorphan hbr, phenylephrine hcl and acetaminophen, dextromethorphan hbr, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-191

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-191-48	4 in 1 CARTON	06/20/2022
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 BLISTER PACK	32
Part 2	4 BLISTER PACK	16

Part 1 of 2

DAYTIME 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Product Information
Item Code (Source)	NDC: 37808-093
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 YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL (Oblong shaped)	Size	21mm
Flavor		Imprint Code	70
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK; 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	06/20/2022

Part 2 of 2

NIGHTIME 
acetaminophen dextromethorphan hbr doxylamine succinate capsule, liquid filled

Product Information
Item Code (Source)	NDC: 37808-095
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 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)
GELATIN (UNII: 2G86QN327L)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SHELLAC (UNII: 46N107B71O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN (UNII: 6O92ICV9RU)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	green	Score	no score
Shape	OVAL (Oblong shaped)	Size	21mm
Flavor		Imprint Code	71
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 in 1 BLISTER PACK; 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	06/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/20/2022

Labeler - H-E-B (007924756)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(37808-191)