DAYTIME NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, phenylephrine hci, doxylamine succinate 325, 10/15, 5, 6.25 mg softgels kit

Daytime Nighttime Cold and Flu by

Drug Labeling and Warnings

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

Drug Details [pdf]

Daytime Cold & Flu Drug Facts

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 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

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 DOCTOR

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 DOCTOR/PHARMACIST

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

WHEN USING

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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 4 hrs

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs: do not use

OTHER SAFETY INFORMATION

Other information

• store at room temperature

INACTIVE INGREDIENT

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

QUESTIONS

Questions or comments? Call 1-877-290-4008

Nighttime Cold & Flu Drug Facts

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 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

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 DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

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

WHEN USING

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

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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 as well as 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 hours

• 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 SAFETY INFORMATION

Other information

• store at room temperature

INACTIVE INGREDIENT

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

QUESTIONS

Questions or comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAYTIME NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, phenylephrine hci, doxylamine succinate 325, 10/15, 5, 6.25 mg softgels kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-695

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-695-48	4 in 1 CARTON	06/07/2023
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	16   in 4
Part 2	4 BLISTER PACK	32   in 4

Part 1 of 2

NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate 325, 15, 6.25 mg softgels capsule, liquid filled

Product Information
Item Code (Source)	NDC: 49483-694
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
SHELLAC (UNII: 46N107B71O)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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	06/07/2023

Part 2 of 2

DAYTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, phenylephrine hci 325, 10, 5 mg softgels capsule, liquid filled

Product Information
Item Code (Source)	NDC: 49483-693
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SHELLAC (UNII: 46N107B71O)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
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	06/07/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/07/2023

Labeler - TIME CAP LABORATORIES INC. (037052099)

Registrant - TIME CAP LABORATORIES INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(49483-695)