Leader 44-470c

SPL v3

SPL

SPL Set ID 0c94780d-e901-43fc-ad8a-80c5d61ea47b

Route

ORAL

Published

Effective Date 2025-10-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)

Inactive Ingredients

Starch, Corn Croscarmellose Sodium Crospovidone, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Silicon Dioxide Stearic Acid Sucralose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 44;470 Shape: oval Color: white Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-10-25

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- nasal congestion
- cough
- sore throat
- sinus congestion and pressure
temporarily reduces fever
helps clear nasal passages
promotes nasal and sinus drainage

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:

blisters
rash
skin reddening

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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

do not take more than directed
adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole - do not crush, chew, or dissolve
- 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.
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.
if you have ever had an allergic reaction to this product or any of its ingredients

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, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

LEADER™

NDC 70000-0652-1

Daytime

Multi-Symptom

Cold Relief

Acetaminophen | Dextromethorphan HBr | Phenylephrine HCl

Pain Reliever / Fever Reducer | Cough Suppressant | Nasal Decongestant

Pseudoephedrine Free

Temporarily Relieves: Headache, Fever,

Sore Throat, Cough, Nasal Congestion

24 CAPLETS with cool blast flavor

Actual Size

100% Money

Back Guarantee

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

50844 ORG072247008

All LEADER™ Brand

Products Have A

100%

Money Back

Guarantee

Return to place of

purchase if not satisfied.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

©2023 Cardinal Health. All Rights Reserved. CARDINAL

HEALTH, the Cardinal Health LOGO, LEADER, and the LEADER

LOGO are trademarks or registered trademarks of Cardinal

Health.

CIN 5857552 REV. 7/23

Leader 44-470

When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, 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 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

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have

liver disease
diabetes
heart disease
thyroid disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

Uses

temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- nasal congestion
- cough
- sore throat
- sinus congestion and pressure
temporarily reduces fever
helps clear nasal passages
promotes nasal and sinus drainage

Purpose

Pain reliever/fever reducer

Cough suppressant

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:

blisters
rash
skin reddening

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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

do not take more than directed
adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole - do not crush, chew, or dissolve
- 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.
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.
if you have ever had an allergic reaction to this product or any of its ingredients

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

LEADER™

NDC 70000-0652-1

Daytime

Multi-Symptom

Cold Relief

Acetaminophen | Dextromethorphan HBr | Phenylephrine HCl

Pain Reliever / Fever Reducer | Cough Suppressant | Nasal Decongestant

Pseudoephedrine Free

Temporarily Relieves: Headache, Fever,

Sore Throat, Cough, Nasal Congestion

24 CAPLETS with cool blast flavor

Actual Size

100% Money

Back Guarantee

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

50844 ORG072247008

All LEADER™ Brand

Products Have A

100%

Money Back

Guarantee

Return to place of

purchase if not satisfied.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

CIN 5857552 REV. 7/23

Leader 44-470

When Using This Product (When using this product)

do not exceed recommended dosage.

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

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, 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, (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

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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

liver disease
diabetes
heart disease
thyroid disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough that occurs with too much phlegm (mucus)

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.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these common cold and flu symptoms: minor aches and pains headache nasal congestion cough sore throat sinus congestion and pressure temporarily reduces fever helps clear nasal passages promotes nasal and sinus drainage", "Purpose": "Pain reliever/fever reducer Cough suppressant 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: blisters rash skin reddening 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "Directions": "do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve 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. 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. if you have ever had an allergic reaction to this product or any of its ingredients", "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, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide ", "Questions or comments?": "1-800-426-9391", "Principal Display Panel": "LEADER™ NDC 70000-0652-1 Daytime Multi-Symptom Cold Relief Acetaminophen | Dextromethorphan HBr | Phenylephrine HCl Pain Reliever / Fever Reducer | Cough Suppressant | Nasal Decongestant Pseudoephedrine Free Temporarily Relieves: Headache, Fever, Sore Throat, Cough, Nasal Congestion 24 CAPLETS with cool blast flavor Actual Size 100% Money Back Guarantee TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org 50844 ORG072247008 All LEADER™ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 ©2023 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. CIN 5857552 REV. 7/23 Leader 44-470", "When using this product": "do not exceed recommended dosage.", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur pain, nasal congestion, 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 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 Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg", "Ask a doctor before use if you have": "liver disease diabetes heart disease thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin. "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:48.476023 · Updated: 2026-03-14T23:13:16.476899