Equaline 44-466c

SPL v15

SPL

SPL Set ID f3fc270a-92fc-46d5-b187-44e875c3abb9

Route

ORAL

Published

Effective Date 2026-02-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Phenylephrine (5 mg)

Inactive Ingredients

Starch, Corn 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 Sodium Starch Glycolate Type A Potato Stearic Acid Sucralose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 44;466 Shape: oval Color: green Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2005-07-26

Description

Acetaminophen 325 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer

Nasal decongestant

Description

Acetaminophen 325 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- minor aches and pains
- headache
- nasal congestion
- sinus congestion and pressure
helps decongest sinus openings and passages
promotes sinus drainage
helps clear nasal passages
temporarily reduces fever

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.

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 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients

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

Questions Or Comments?

1-855-423-2630

Principal Display Panel

NDC 41163-664-08

EQUALINE®

compare to

Tylenol®

SINUS + HEADACHE

active ingredients*

daytime sinus

congestion & pain

acetaminophen

(pain reliever/fever reducer)

phenylephrine HCl

(nasal decongestant)

non-drowsy

relieves:

• sinus headache & pressure

• nasal congestion

PSEUDOEPHEDRINE FREE

24 caplets

actual size

TAMPER EVIDENT: DO NOT

USE IF PACKAGE IS

OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF

TAMPERING

100% Quality

GUARANTEED

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the

registered trademark Tylenol® SINUS + HEADACHE.

50844 REV0721H46608

Equaline 44-466C

When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
pain or nasal congestion gets worse or lasts more than 7 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present

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. 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

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have

difficulty in urination due to enlargement of the prostate gland
liver disease
heart disease
diabetes
thyroid disease
high blood pressure

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

Uses

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- minor aches and pains
- headache
- nasal congestion
- sinus congestion and pressure
helps decongest sinus openings and passages
promotes sinus drainage
helps clear nasal passages
temporarily reduces fever

Purpose

Pain reliever/fever reducer

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.

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 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-855-423-2630

Principal Display Panel

NDC 41163-664-08

EQUALINE®

compare to

Tylenol®

SINUS + HEADACHE

active ingredients*

daytime sinus

congestion & pain

acetaminophen

(pain reliever/fever reducer)

phenylephrine HCl

(nasal decongestant)

non-drowsy

relieves:

• sinus headache & pressure

• nasal congestion

PSEUDOEPHEDRINE FREE

24 caplets

actual size

TAMPER EVIDENT: DO NOT

USE IF PACKAGE IS

OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF

TAMPERING

100% Quality

GUARANTEED

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the

registered trademark Tylenol® SINUS + HEADACHE.

50844 REV0721H46608

Equaline 44-466C

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 or nasal congestion gets worse or lasts more than 7 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present

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

Phenylephrine HCl 5 mg

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

difficulty in urination due to enlargement of the prostate gland
liver disease
heart disease
diabetes
thyroid disease
high blood pressure

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 symptoms associated with hay fever or other respiratory allergies, and the common cold: minor aches and pains headache nasal congestion sinus congestion and pressure helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever", "Purpose": "Pain reliever/fever reducer 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.", "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 15°-30°C (59°-86°F) see end flap for expiration date and lot number", "Inactive ingredients": "corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide", "Questions or comments?": "1-855-423-2630", "Principal Display Panel": "NDC 41163-664-08 EQUAL INE® compare to Tylenol® SINUS + HEADACHE active ingredients* daytime sinus congestion & pain acetaminophen (pain reliever/fever reducer) phenylephrine HCl (nasal decongestant) non-drowsy relieves: • sinus headache & pressure • nasal congestion PSEUDOEPHEDRINE FREE 24 caplets actual size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 100% Quality GUARANTEED DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA 855-423-2630 *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® SINUS + HEADACHE. 50844 REV0721H46608 Equaline 44-466C", "When using this product": "do not exceed recommended dosage.", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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. 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 Phenylephrine HCl 5 mg", "Ask a doctor before use if you have": "difficulty in urination due to enlargement of the prostate gland liver disease heart disease diabetes thyroid disease high blood pressure", "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: 2026-02-15T12:05:34.388902 · Updated: 2026-03-14T23:13:55.868201