DAYTIME AND NIGHTTIME COLD/FLU RELIEF SOFTGELS - COMBO PACK- acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate kit

DayTime and Nighttime Cold/Flu Relief Softgels - Combo Pack by

Drug Labeling and Warnings

DayTime and Nighttime Cold/Flu Relief Softgels - Combo Pack by is a Otc medication manufactured, distributed, or labeled by ARMY AND AIR FORCE EXCHANGE SERVICE, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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DayTime COLD/FLU RELIEF

ACTIVE INGREDIENT

Drug Facts

Active ingredients
(in each Softgel)

Acetaminophen ................325 mg

Dextromethorphan HBr ......10 mg

Phenylephrine HCl .........5 mg

Purpose

Acetaminophen ........................Pain reliever/Fever reducer

Dextromethorphan HBr .............Cough suppressant

Phenylephrine HCl ............... Nasal Decongestant

INDICATIONS & USAGE

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

WARNINGS

Warnings 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 daily 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, lasts 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 products 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 enlarged prostate
gland
■ cough that occurs with too much phlegm
(mucus)
■ persistant 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 accidental 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.

DOSAGE & ADMINISTRATION

Directions
■ take only as directed (see Warnings)
■ do not exceed 4 doses per 24 hours

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

■ even if taking DayTime during day and Nighttime during night, total
limit per day is 4 doses per 24-hour period.

OTHER SAFETY INFORMATION

Other information
■ Store at room temperature 20-25º C (68-77º F)
■ avoid excessive heat

INACTIVE INGREDIENT

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

QUESTIONS

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

------------

Nighttime COLD/FLU RELIEF

ACTIVE INGREDIENT

Drug Facts

Active ingredients
(in each Softgel)

Acetaminophen ................325 mg

Dextromethorphan HBr ......15 mg

Doxylamine succinate .........6.25 mg

Purpose

Acetaminophen ........................Pain reliever/fever reducer

Dextromethorphan HBr .............Cough suppressant

Doxylamine succinate ............... Antihistamine

INDICATIONS & USAGE

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

WARNINGS

Warnings 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 daily while using this product.

Allergy Alert: Acetaminophen may cause
severe skin reactions. Symptoms may
include ■ skin reddening ■ blisters ■ rash.
If skin reaction occurs, stop use and seek
medical help right away.

Sore throat warning: If sore throat is
severe, lasts 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 products 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 this 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 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 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 accidental 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.

DOSAGE & ADMINISTRATION

Directions
■ take only as directed (see Warnings)
■ do not exceed 4 doses per 24 hours

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

■ even if taking DayTime during day and Nighttime during night, total
l  imit per day is 4 doses per 24-hour period.

STORAGE AND HANDLING

Other information
■ Store at room temperature 20-25º C (68-77º F)
■ avoid excessive heat

INACTIVE INGREDIENT

Inactive ingredients
D&C Yellow # 10, FD&C
Blue # 1, Gelatin, Glycerin,
Polyethylene glycol,
Povidone, Propylene glycol,
Purified water, Sorbitol
sorbitan solution, Titanium
dioxide.

QUESTIONS

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

Principal Display Package Label: exchange select DayTime and Nighttime Cold/Flu Relief Softgels - Combo Pack

DayTime Cold/Flu Relief Nighttime Cold/Flu Relief

32 Softgels   /   16 Softgels

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

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

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS
AND PRODUCT INFORMATION.

SATISFACTION GUARANTEED OR YOUR MONEY BACK.

Manufactured For Your Military Exchanges
By AptaPharma Inc.,
1533 Union Avenue, Pennsauken, NJ 08110
1-877-798-5944 aptapharma.com

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INGREDIENTS AND APPEARANCE

DAYTIME AND NIGHTTIME COLD/FLU RELIEF SOFTGELS - COMBO PACK 
acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55301-605

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55301-605-05	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	01/01/2025

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 hbr, phenylephrine hcl capsule, liquid filled

Product Information
Item Code (Source)	NDC: 55301-604
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	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		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 Drug	M012	01/01/2025

Part 2 of 2

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

Product Information
Item Code (Source)	NDC: 55301-603
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
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		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 Drug	M012	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/01/2025

Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)

Registrant - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(55301-605, 55301-604, 55301-603)