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

DAYTIME NIGHTTIME COLD FLU RELIEF by

Drug Labeling and Warnings

DAYTIME NIGHTTIME COLD FLU RELIEF by is a Otc medication manufactured, distributed, or labeled by APNAR PHARMA LP, APNAR PHARMA LLP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients for Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

ACTIVE INGREDIENT

Active ingredients for Nighttime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

PURPOSE

Purposes

for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

PURPOSE

Purposes

for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

INDICATIONS & USAGE

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

Uses

Nighttime

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

WARNINGS

Warnings

Daytime

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

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this products

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.

Nighttime

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

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this products

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

• 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.

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 such as occurs 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

• do not exceed recommended dosage
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• 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
• redness or swelling is present
• new symptoms occur
• fever gets worse or lasts more than 3 days
• 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 headache that lasts.

These could be a signs of a serious condition

If pregnant or breast-feeding,

ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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 (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

Daytime

• do not take more than directed (see Overdose warning)
• do not take more than 4 doses in 24 hours
• swallow whole; do not crush, chew, or dissolve

adults and children 12 years and over: take 2 softgels with water every 4 hours.

children under 12 years: do not use

Nighttime

• do not take more than directed (see Overdose warning)
• do not take more than 4 doses in 24 hours
• swallow whole; do not crush, chew, or dissolve

adults and children 12 years and over: take 2 softgels with water every 6 hours

children under 12 years: do not use

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

Daytime

Gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, FD&C yellow #6, FD&C Red #40 , white ink

Nighttime

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

QUESTIONS

Questions or comments?

Call 1-855-642-2594

PRINCIPAL DISPLAY PANEL

†Compare to the active ingredients in Vicks® DayQuil® and NyQuil® Cold & Flu LiquiCaps®

Daytime

NDC: 24689-152-01

Multi-Symptom Cold & Flu Relief

Acetaminophen 325 mg- Pain reliever / Fever reducer

Dextromethorphan HBr 10 mg - Cough suppressant

Phenylephrine HCI 5 mg - Nasal decongestant

Relieves:

• Aches, fever, sore throat
• Cough
• Nasal congestion

Non-drowsy

Alcohol-Free

Antihistamine-Free

Softgels**

(** Liquid-filled capsules)

Nighttime

Multi-Symptom Cold & Flu Relief

Acetaminophen 325 mg - Pain reliever / Fever reducer

Dextromethorphan HBr 15 mg - Cough suppressant

Doxylamine succinate 6.25 mg - Antihistamine

Relieves:

• Aches, fever, sore throat
• Cough
• Runny nose, sneezing

Softgels**

Alcohol-free

(**Liquid-filled capsules)

When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing.

†This product is not manufactured or distributed by The Procter & Gamble Company.

Vicks®, DayQuil®, NyQuil®, and LiquiCaps® are registered trademarks of the Procter and Gamble Company.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:

APNAR PHARMA LP

CHINO, CA, USA, 91710

Rev.: 04/2023

INGREDIENTS AND APPEARANCE

DAYTIME NIGHTTIME COLD FLU RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24689-152

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24689-152-01	1 in 1 CARTON; Type 0: Not a Combination Product	05/11/2023

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

Part 1 of 2

NIGHTTIME COLD FLU RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule

Product Information
Item Code (Source)	NDC: 24689-157
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
SORBITAN (UNII: 6O92ICV9RU)
POVIDONE (UNII: FZ989GH94E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)
GELATIN (UNII: 2G86QN327L)

Product Characteristics
Color	green	Score	no score
Shape	CAPSULE	Size	23mm
Flavor		Imprint Code	AA7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		16 in 1 CARTON
1		1 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 Drug	M012	05/11/2023

Part 2 of 2

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

Product Information
Item Code (Source)	NDC: 24689-158
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
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN (UNII: 6O92ICV9RU)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	23mm
Flavor		Imprint Code	AA6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		32 in 1 CARTON
1		1 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 Drug	M012	05/11/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/11/2023

Labeler - APNAR PHARMA LP (079568229)

Establishment
Name	Address	ID/FEI	Business Operations
APNAR PHARMA LLP		118530917	manufacture(24689-152) , analysis(24689-152)