HEALTHY ACCENTS DAY TIME NIGHT TIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl 
DZA Brands LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DZA Brands, LLC Day Time Night Time Drug Facts

Active ingredients for NIGHTTIME (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredients for DAYTIME (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose (NIGHTTIME ONLY)

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose (DAYTIME ONLY)

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

nasal congestion (DAYTIME ONLY)
cough due to minor throat and bronchial irritation
sore throat
headache
minor aches and pains
fever
relieves runny nose and sneezing (NIGHTTIME ONLY)

Warnings

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

more than 8 softgels in 24 hours (Nighttime) or more than 12 softgels in 24 hours (Daytime), which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using these products

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

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.
to make a child sleepy

Ask a doctor before use if you have

heart disease (DAYTIME ONLY)
thyroid disease (DAYTIME ONLY)
diabetes (DAYTIME ONLY)
high blood pressure (DAYTIME ONLY)
cough that occurs with too much phlegm (mucus)
liver disease
persistent or chronic cough as occurs with smoking, asthma or emphysema
trouble urinating due to an enlarged prostate gland
glaucoma (NIGHTTIME ONLY)
a breathing problem such as emphysema or chronic bronchitis (NIGHTTIME ONLY)

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using these products

do not use more than directed

In addition, when using NIGHTTIME:

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 and tranquilizers may increase drowsiness

Stop use and ask a doctor if

you get nervous, dizzy or sleepless (DAYTIME ONLY)
redness or swelling is present
fever gets worse or lasts more than 3 days
new symptoms occur
pain, nasal congestion or cough gets worse or lasts more than 7 days
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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

take only as recommended - see Liver warning
take Nighttime OR Daytime

NIGHTTIME SOFTGELS

do not exceed 4 doses per 24 hours

adults and children 12 years and over

2 softgels with water every

6 hours

children 4 to under 12 years

ask a doctor

children under 4 years

do not use

DAYTIME SOFTGELS

do not exceed 6 doses per 24 hours

adults and children 12 years and over

2 softgels with water every

4 hours

children 4 to under 12 years

ask a doctor

children under 4 years

do not use

when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

NIGHTTIME D&C yellow no. 10, edible ink, FD&C blue no. 1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

DAYTIME edible ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

1-866-322-2439

Principal Display Panel

SEE NEW WARNINGS INFORMATION

Day Time

Multi-Symptom

Cold/Flu Relief

Relieves Major Cold/Flu-Like Symptoms So You Can Cope

Pain Reliever / Fever Reducer

Cough Suppressant / Nasal Decongestant

Aches, Fever - Acetaminophen

Cough - Dextromethorphan HBr

Nasal Congestion - Phenylephrine HCl

Non-Drowsy

Compare to active ingredients of Vicks® DayQuil®

Antihistamine Free

Alcohol Free

SEE NEW WARNINGS INFORMATION

Night Time

Multi-Symptom

Cold/Flu Relief

Relieves Cold & Flu-Like Symptoms So You Can Rest

Fever Reducer / Pain Reliever

Antihistamine / Cough Suppressant

Aches, Fever - Acetaminophen

Cough - Dextromethorphan HBr

Sneezing, Runny Nose - Doxylamine Succinate

Compare to active ingredients of Vicks® NyQuil®

Alcohol Free

Day Time Night Time Carton Image 1

Day Time Night Time Carton Image 1

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Day Time Night Time Carton Image 1

Day Time Night Time Carton Image 2

HEALTHY ACCENTS DAY TIME NIGHT TIME 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-090
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-090-051 in 1 CARTON; Type 0: Not a Combination Product04/01/200808/08/2015
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 20 
Part 22 BLISTER PACK 20 
Part 1 of 2
HEALTHY ACCENTS NIGHTTIME  COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code L977
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/24/200808/08/2015
Part 2 of 2
HEALTHY ACCENTS DAYTIME 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code L994
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/24/200808/08/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/200808/08/2015
Labeler - DZA Brands LLC (090322194)

Revised: 11/2017
 
DZA Brands LLC