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 P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients for Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients for 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 flu symptoms
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

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 these 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: This product 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 product

Alergy 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 following by fever, headache, rash, nausea, 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.

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.

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

Other information

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

Inactive ingredients

DAYTIME

 FD&C yellow #6, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

NIGHTTIME

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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

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

DAYTIME

Multi-Symptom

Cold & Flu Relief

acetaminophen (Pain reliever / Fever reducer)

dextromethorphan HBr (Cough suppressant)

phenylephrine HCI (Nasal decongestant)

• non-drowsy
• alcohol-free
• antihistamine-free

Softgels**

(** Liquid-filled capsules)

NIGHTTIME

multi-symptom

Cold & Flu Relief

acetaminophen (Pain reliever / Fever reducer)

dextromethorphan HBr (Cough suppressant)

Doxylamine succinate (Antihistamine)

• Alcohol-free

Softgels**

(**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: PL Developments

200 Hicks Street, Westbury 11590

Product Label

WELLNESS BASICS Daytime Nighttime Cold & Flu Relief

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: 59726-201

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59726-201-48	1 in 1 KIT; Type 0: Not a Combination Product	10/30/2019

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
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
MANNITOL (UNII: 3OWL53L36A)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	PC10
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 FINAL	part341	10/30/2019

Part 2 of 2

DAYTIME COLD FLU RELIEF 
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 YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
MANNITOL (UNII: 3OWL53L36A)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	PC9
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 FINAL	part341	10/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/30/2019

Labeler - P & L Development, LLC (800014821)