Exchange Select Nighttime Cold/flu Relief

Exchange Select Nighttime Cold/flu Relief
SPL v4
SPL
SPL Set ID 029e6215-b72d-4fd0-8918-db1abcc4490a
Route
ORAL
Published
Effective Date 2025-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol Sorbitan Titanium Dioxide

Identifiers & Packaging

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

Description

Drug Facts Active ingredients (in each Softgel) Acetaminophen ................325 mg Dextromethorphan HBr ......15 mg Doxylamine succinate .........6.25 mg


Medication Information

Warnings and Precautions

WarningsLiver warning : This product

contains acetaminophen. Severe liver

damage may occur if you take ■ more than

4doses 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.

Indications and 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 and sneezing

Dosage and Administration

Directions

■ take only as directed (see Warning)

■ do not exceed 4 doses per 24 hours

adults &

children

12 yrs

& over

2 soft gels with water every 6 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 ensure

correct dosing.

Description

Drug Facts Active ingredients (in each Softgel) Acetaminophen ................325 mg Dextromethorphan HBr ......15 mg Doxylamine succinate .........6.25 mg

Section 34088-5

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.

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a

Poison Control Center right away.

Section 50566-9

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.

Section 50567-7

When using this produc t, 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, and tranquilizers may

increase drowsiness

Section 50568-5

Ask a doctor or pharmacistbefore use if you are

■ taking sedatives or tranquilizers

■ taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before useif 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 an enlarged prostate

gland

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 ■ to make a child sleep.

Section 51727-6

Inactive ingredients

D&C Yellow # 10, FD&C

Blue # 1, 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

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

Section 55106-9

Drug Facts

Active ingredients

(in each Softgel)



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

Dextromethorphan HBr ......15 mg

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

Section 60561-8

Other information

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

■ avoid excessive heat

Product Label: Exchange Select Nighttime Cold/flu Relief

exchange select

Nighttime

Cold/Flu Relief

24 Softgels

Manufactured For Your Military Exchange

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: ■ cough due to minor throat &

bronchial irritation ■ sore throat ■ headache

■ minor aches and pain ■ fever ■ runny

nose and sneezing

Dosage and Administration (34068-7)

Directions

■ take only as directed (see Warning)

■ do not exceed 4 doses per 24 hours

adults &

children

12 yrs

& over

2 soft gels with water every 6 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 ensure

correct dosing.

Warnings and Precautions (34071-1)

WarningsLiver warning : This product

contains acetaminophen. Severe liver

damage may occur if you take ■ more than

4doses 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.

Section 34088-5 (34088-5)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a

Poison Control Center right away.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this produc t, 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, and tranquilizers may

increase drowsiness

Section 50568-5 (50568-5)

Ask a doctor or pharmacistbefore use if you are

■ taking sedatives or tranquilizers

■ taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before useif 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 an enlarged prostate

gland

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 ■ to make a child sleep.

Section 51727-6 (51727-6)

Inactive ingredients

D&C Yellow # 10, FD&C

Blue # 1, 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

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

Section 55106-9 (55106-9)

Drug Facts

Active ingredients

(in each Softgel)



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

Dextromethorphan HBr ......15 mg

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

Section 60561-8 (60561-8)

Other information

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

■ avoid excessive heat

Product Label: Exchange Select Nighttime Cold/flu Relief (Product Label: exchange select NightTime Cold/Flu Relief)

exchange select

Nighttime

Cold/Flu Relief

24 Softgels

Manufactured For Your Military Exchange

By AptaPharma Inc.,

1533 Union Avenue, Pennsauken, NJ 08110

1-877-798-5944

aptapharma.com

res


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