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 Care One (American Sales Company). 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 that lasts 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 use more than directed

NIGHTTIME

• 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 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

 butylated hydroxyanisole*, butylated hydroxytoluene*, carminic acid*, D&C yellow #10*, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium metabisulfite*, sorbitan*, sorbitol

*may contain this ingredient

NIGHTTIME

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

*may contain this ingredient

Questions or comments?

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

Principal Display Panel

DAYTIME

MULTI-SYMPTOM

COLD / FLU RELIEF

Pain reliever - Fever Reducer - Acetaminophen

Cough Suppressant - Dextromethorphan HBr

Nasal Decongestant - Phenylephrine HCI

Relieves Major cold & Flu Symptoms:

Aches & Fever,Sore Throat, Coughing, Congestion

SOFTGELS

NIGHTTIME

MULTI-SYMPTOM

COLD / FLU RELIEF

Pain Reliever - Fever Reducer - Acetaminophen

Cough Suppressant - Dextromethorphan HBr

Antihistamine - Doxylamine succinate

Relieves Cold & Flu Symptoms

So You Can Rest

SOFTGELS

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

†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.

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

DISTRIBUTED BY

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

Product Label

CareOne DayTime NightTime Multi-Symptom 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: 41520-872

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-872-48	1 in 1 CARTON; Type 0: Not a Combination Product	11/30/2016

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 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	10 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)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	P30;94A;215;P120
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	11/30/2016

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
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
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)
CARMINIC ACID (UNII: CID8Z8N95N)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	P19;95A;512;P119
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	11/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/30/2016

Labeler - Care One (American Sales Company) (809183973)