Exchange Select 44-464

SPL v16

SPL

SPL Set ID 91268cd0-c151-4744-a715-a57af3f3a314

Route

ORAL

Published

Effective Date 2025-06-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Diphenhydramine (12.5 mg) Phenylephrine (5 mg)

Inactive Ingredients

Starch, Corn Croscarmellose Sodium Crospovidone, Unspecified D&c Yellow No. 10 Aluminum Lake Fd&c Blue No. 1 Aluminum Lake Fd&c Red No. 40 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 44;464 Shape: oval Color: green Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2005-06-15

Description

Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever Antihistamine Nasal decongestant

Medication Information

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Description

Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves these symptoms of hay fever and the common cold:
- runny nose
- sneezing
- headache
- minor aches and pains
- nasal congestion
temporarily relieves these additional symptoms of hay fever:
- itching of the nose or throat
- itchy, watery eyes

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
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.

Directions

do not take more than directed
adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 10 caplets in 24 hours
children under 12 years: ask a doctor

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.
with any other product containing diphenhydramine, even one used on skin
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.

Other Information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive Ingredients

corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

exchange✓select™

ALLERGY &

SINUS HEADACHE

Acetaminophen

Diphenhydramine HCl

Phenylephrine HCl

Pain Reliever

Antihistamine

Nasal Decongestant

Relieves

Sinus Headache, Sneezing,

Runny Nose, Itchy Throat,

Sinus Congestion, Sinus Pressure,

& Itchy, Watery Eyes

Actual Size

24 Caplets

✓quality

value

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844 REV1024L46408

"SATISFACTION GUARANTEED

OR YOUR MONEY BACK"

Manufactured For Your Military Exchanges

Distributed by: LNK International, Inc.

Hauppauge, NY 11788

1-800-426-9391

Exchange Select 44-464

When Using This Product

do not exceed recommended dosage
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
pain or nasal congestion 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

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have

liver disease
glaucoma
thyroid disease
heart disease
diabetes
high blood pressure
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves these symptoms of hay fever and the common cold:
- runny nose
- sneezing
- headache
- minor aches and pains
- nasal congestion
temporarily relieves these additional symptoms of hay fever:
- itching of the nose or throat
- itchy, watery eyes

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
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.

Directions

do not take more than directed
adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 10 caplets in 24 hours
children under 12 years: ask a doctor

Do Not Use (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.
with any other product containing diphenhydramine, even one used on skin
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.

Other Information (Other information)

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

exchange✓select™

ALLERGY &

SINUS HEADACHE

Acetaminophen

Diphenhydramine HCl

Phenylephrine HCl

Pain Reliever

Antihistamine

Nasal Decongestant

Relieves

Sinus Headache, Sneezing,

Runny Nose, Itchy Throat,

Sinus Congestion, Sinus Pressure,

& Itchy, Watery Eyes

Actual Size

24 Caplets

✓quality

value

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844 REV1024L46408

"SATISFACTION GUARANTEED

OR YOUR MONEY BACK"

Manufactured For Your Military Exchanges

Distributed by: LNK International, Inc.

Hauppauge, NY 11788

1-800-426-9391

Exchange Select 44-464

When Using This Product (When using this product)

do not exceed recommended dosage
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur
pain or nasal congestion 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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease
glaucoma
thyroid disease
heart disease
diabetes
high blood pressure
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms of hay fever and the common cold: runny nose sneezing headache minor aches and pains nasal congestion temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes", "Purpose": "Pain reliever Antihistamine Nasal decongestant", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 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.", "Directions": "do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor", "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. with any other product containing diphenhydramine, even one used on skin 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.", "Other information": "TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number", "Inactive ingredients": "corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, talc, titanium dioxide", "Questions or comments?": "1-800-426-9391", "Principal Display Panel": "exchange ✓select™ ALLERGY & SINUS HEADACHE Acetaminophen Diphenhydramine HCl Phenylephrine HCl Pain Reliever Antihistamine Nasal Decongestant Relieves Sinus Headache, Sneezing, Runny Nose, Itchy Throat, Sinus Congestion, Sinus Pressure, & Itchy, Watery Eyes Actual Size 24 Caplets ✓quality value TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 REV1024L46408 "SATISFACTION GUARANTEED OR YOUR MONEY BACK" Manufactured For Your Military Exchanges Distributed by: LNK International, Inc. Hauppauge, NY 11788 1-800-426-9391 Exchange Select 44-464", "When using this product": "do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur pain or nasal congestion 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", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "I n case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Active ingredients (in each caplet)": "Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg", "Ask a doctor before use if you have": "liver disease glaucoma thyroid disease heart disease diabetes high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:24.668600 · Updated: 2026-03-14T23:09:10.710567