DAYTIME AND NIGHTTIME COLD/FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate kit

Daytime and Nighttime Cold/Flu Relief by

Drug Labeling and Warnings

Daytime and Nighttime Cold/Flu Relief by is a Otc medication manufactured, distributed, or labeled by Pharmacy Value Alliance, LLC, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each Softgel) (DAYTIME ONLY)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients (in each Softgel) (NIGHTTIME ONLY)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose (DAYTIME ONLY)

Acetaminophen …………...... Pain reliever/fever reducer
Dextromethorphan HBr …... Cough suppressant
Phenylephrine HCl ………..... Nasal decongestant

Purpose (NIGHTTIME ONLY)

Acetaminophen ………….. Pain reliever/fever reducer
Dextromethorphan HBr …. Cough suppressant
Doxylamine succinate………. Antihistamine

Uses (DAYTIME ONLY)

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

Uses (NIGHTTIME ONLY)

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

Warnings (DAYTIME ONLY)

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
more than 4 doses in 24 hrs, which is the maximum daily amount for this product
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,
occurs with or is 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.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product do not use more than directed

Stop use and ask a doctor if
you get nervous, dizzy or sleepless
symptoms get worse or last more than 5 days (children) or 7 days (adults)
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.

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 children, even if you do not notice any signs or symptoms.

Warnings (NIGHTTIME ONLY)

Liver warning: This product contains acetaminophen.  Severe
liver damage may occur if you take:
more than 4 doses in 24 hrs, which is the maximum daily amount for this product
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,
occurs with or is 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 sleep

Ask a doctor before use if you have liver disease glaucoma
cough that occurs with too much phlegm (mucus)
a breathing problem or chronic cough that lasts or as occurs with smoking,
  asthma, chronic bronchitis or emphysema
trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using thls product
do not use more than directed
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 & tranquilizers may increase drowsiness

Stop use and ask a doctor if
pain or cough gets worse or lasls more than 7days
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.

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
children, even if you do not notice any signs or symptoms.

Directions (DAYTIME ONLY)

• take only as directed (see Warnings)
• do not exceed 4 doses in 24 hrs   

• adults and children 12 yrs & over: 2 softgels with water every 4 hrs
• children 4 to under 12 yrs: ask a doctor
• children under 4 yrs: do not use

When using other Daytime or Nighttime products,
carefully read each label to ensure correct dosing

Directions (NIGHTTIME ONLY)

• take only as directed (see Warnings)
• do not exceed 4 doses in 24 hrs   

• adults and children 12 yrs & over: 2 softgels with water every 6 hrs
• children 4 to under 12 yrs: ask a doctor
• children under 4 yrs: do not use

When using other Daytime or Nighttime products,
carefully read each label to ensure correct dosing

Other information (DAYTIME & NIGHTTIME)

• store at room temperature 20°-25°C (68°-77°F)
• avoid excessive heat

Inactive ingredients (DAYTIME ONLY)

FD&C Red #40 FD&C Yellow #6,
Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,
Purified water, Sorbitol sorbitan solution, Titanium dioxide

Inactive ingredients (NIGHTTIME ONLY)

D&C yellow # 10, FD&C blue #1,
Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,
Purified water, Sorbitol sorbitan solution, Titanium dioxide

Questions? (DAYTIME & NIGHTTIME)

Call weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944

Principal Display Package Label

Premier                                                 **COMPARE TO THE ACTIVE INGREDIENTS IN
Value®                                                   VICKS® DAYQUIL® AND VICKS® NYQUIL® LIQUICAPS​​​®​

Non-Drowsy                                                               Multi-Symptom
Daytime                                                                      Nighttime

                                COLD/FLU RELIEF

Acetaminophen                                                             Acetaminophen/ Dextromethorphan HBr/
Dextromethorphan HBr/Phenylephrine HCl            Doxylamine Succinate

Aches, Fever & Sore Throat                                         Headache, Fever, Sore Throat, Minor Aches and Pains
Nasal Congestion                                                        Sneezing, Runny Nose
Cough                                                                          Cough

Alcohol - Free
Antihistamine - Free

32 Softgels                                                                      16 Softgels

48 Total
Softgels

   INDEPENDENTLY TESTED
                  PV
SATISFACTION GUARANTEED

**This product is not manufactured or distributed by Procter & Gamble, owner of the
registered trademark Vicks® DayQuil® LiquiCaps®.

**This product is not manufactured or distributed by Procter & Gamble, owner of
the registered trademark Vicks® NyQuil® LiquiCaps®.

Dlstribuled By: Pharmacy Value Alliance, LLC
                          407 East Lancaster Avenue,
                          Wayne, Pa 19087

If for any reason you are not satisfied with
this product, please return it to the store
where purchased for a full refund.

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

KEEP OUTER CARTOIN FOR COMPLETE WARNINGS
AND PRODUCT INFORMATION.

BX-095

1
 987495
   1/20

res

INGREDIENTS AND APPEARANCE

DAYTIME AND NIGHTTIME COLD/FLU RELIEF 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-882

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-882-48	1 in 1 CARTON; Type 0: Not a Combination Product	02/28/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 BLISTER PACK	32
Part 2	2 BLISTER PACK	16

Part 1 of 2

DAYTIME COLD/FLU RELIEF 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

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	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, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (to red)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	604
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 in 1 CARTON
1		8 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

Part 2 of 2

NIGHTTIME COLD/FLU RELIEF 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

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)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	603
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 CARTON
1		8 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	02/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/28/2020

Labeler - Pharmacy Value Alliance, LLC (101668460)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(68016-882) , repack(68016-882)