DAYTIME NIGHTTIME COLD AND FLU RELIEF MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Daytime Nighttime Cold and Flu Relief by

Drug Labeling and Warnings

Daytime Nighttime Cold and Flu Relief by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC, MEDGEL PRIVATE LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients in Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients in Nighttime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

DAYTIME

• temporarily relieves common cold and flu symptoms
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • headache
  • minor aches and pains
  • fever
  • sore throat

NIGHTTIME

• temporarily relieves common cold and fly symptoms
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pain
  • fever
  • runny nose and sneezing

Warnings

DAYTIME and NIGHTTIME

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

• more than 4 doses 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

DAYTIME and NIGHTTIME

• 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

DAYTIME

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

NIGHTTIME

• liver disease
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts such as occur with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

DAYTIME

• taking the blood thinning drug warfarin

NIGHTTIME

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

When using this product,

DAYTIME

do not exceed recommended dosage.

NIGHTTIME

• excitability may occur, especially in children
• avoid alcoholic drinks
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

DAYTIME

• nervousness, dizziness or sleeplessness occur
• pain, cough, and nasal congestion 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.

NIGHTTIME

• 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.

DAYTIME and NIGHTTIME

Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DAYTIME

• do not take more than directed (see Overdose warning )
• do not take more than 4 doses in 24 hours 
• adults and children 12 years and over: take 2 softgels with water every 4 hours
• children 4 to under 12 years of age: ask a doctor
• children under 4 years of age : do not use

Nighttime:

• do not take more than directed (see Overdose warning)
• do not take more than 4 doses in 24 hours
• adults and children 12 years and over: take 2 softgels with water every 6 hours
• children 4 to under 12 years of age: ask a doctor
• children under 4 years of age : do not use

Other information

DAYTIME and NIGHTTIME

• store between 15-30°C (59-86°F)
• avoid excessive heat

Inactive ingredients

Daytime FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide  

Nighttime D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENTS IN VICKS® DAYQUIL® & VICKS® NYQUIL® LIQUICAPS® Cold &Flu LiquiCaps®**

MULTI-SYMPTOM

Daytime Liquid Capsules

Acetaminophen - Pain Reliever / Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Phenylephrine HCl - Nasal Decongestant

Fever, Headache, Sore Throat, Coughing, Minor Aches and Pains, & Nasal Congestion

Non-drowsy, Alcohol-free antihistamine-free

SOFTGELS

MULTI-SYMPTOM

Nite Time

Liquid Capsules

Acetaminophen - Pain Reliever / Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Doxylamine Succinate - Antihistamine

Fever, Headache, Sore Throat, Coughing, Minor Aches and Pains, Runny Nose & Snezzing

Alcohol-free

softgels

**This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil®, NyQuil®, and LiquiCap® are registered trademarks of The Procter and Gamble Company.

INGREDIENTS AND APPEARANCE

DAYTIME NIGHTTIME COLD AND FLU RELIEF   MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0405

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0405-2	1 in 1 CARTON; Type 0: Not a Combination Product	03/11/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	6
Part 2	1 BLISTER PACK	6

Part 1 of 2

NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule

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	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	215
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		6 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	03/11/2020

Part 2 of 2

DAYTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule

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 (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	512
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		6 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	03/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/11/2020

Labeler - Spirit Pharmaceuticals LLC (179621011)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LTD		677385498	manufacture(68210-0405)