Exchange Select Daytime And Nighttime Cold/flu Relief Softgels - Combo Pack

Exchange Select Daytime And Nighttime Cold/flu Relief Softgels - Combo Pack
SPL v2
SPL
SPL Set ID 5f680f37-b3db-450f-b8ca-f9e31a04dc04
Route
ORAL
Published
Effective Date 2025-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (15 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol Sorbitan Titanium Dioxide D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: 603 Shape: oval Color: red Color: green Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

DayTime COLD/FLU RELIEF


Medication Information

Indications and Usage

Uses temporarily relieves common cold/flu

symptoms: ■ nasal congestion ■cough due to

to minor throat & bronchial irritation ■ sore

throat ■ headache ■ minor aches and pains

■ fever

Dosage and 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.

Description

DayTime COLD/FLU RELIEF

Section 42229-5

WarningsLiver 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.

Section 44425-7

Other information

■ Store at room temperature 20-25º C (68-77º F)

■ avoid excessive heat

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50567-7

When using this product, do not use more than directed.

Section 50568-5

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

Section 50569-3

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

Section 50570-1

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.

Section 51727-6

Inactive ingredients FD&C Red # 40, FD&C Yellow # 6,

Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,

Purified water, Sorbitol sorbitan solution, Titanium dioxide

Section 53413-1

Questions?Call Weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1

Purpose

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

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

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

Section 55106-9

Drug Facts

Active ingredients

(in each Softgel)

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

Dextromethorphan HBr ......10 mg

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

Section 60561-8

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.

DayTime COLD/FLU RELIEF

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

res


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves common cold/flu

symptoms: ■ nasal congestion ■cough due to

to minor throat & bronchial irritation ■ sore

throat ■ headache ■ minor aches and pains

■ fever

Dosage and Administration (34068-7)

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.

Section 42229-5 (42229-5)

WarningsLiver 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.

Section 44425-7 (44425-7)

Other information

■ Store at room temperature 20-25º C (68-77º F)

■ avoid excessive heat

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product, do not use more than directed.

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients FD&C Red # 40, FD&C Yellow # 6,

Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,

Purified water, Sorbitol sorbitan solution, Titanium dioxide

Section 53413-1 (53413-1)

Questions?Call Weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

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

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

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

Section 55106-9 (55106-9)

Drug Facts

Active ingredients

(in each Softgel)

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

Dextromethorphan HBr ......10 mg

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

Section 60561-8 (60561-8)

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.

(------------)

DayTime COLD/FLU RELIEF

Principal Display Package Label: Exchange Select Daytime and Nighttime Cold/flu Relief Softgels Combo Pack (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

res


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)