Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID 282c103c-3888-4a35-a5b1-d492ed6892c1

Route

ORAL

Published

Effective Date 2024-03-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Chlorpheniramine (2 mg) Phenylephrine (5 mg)

Inactive Ingredients

Benzyl Alcohol Crospovidone, Unspecified Magnesium Stearate Microcrystalline Cellulose Modified Corn Starch (1-octenyl Succinic Anhydride) Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Starch, Corn Propylene Glycol Water Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid Sucralose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: FRH Shape: oval Color: white Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-03-10

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer Antihistamine Nasal decongestant

Medication Information

Purpose

Pain reliever/Fever reducer Antihistamine Nasal decongestant

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
sinus congestion and pressure
runny nose and sneezing
minor aches and pains
nasal congestion
headache
temporarily relieves these additional symptoms of hay fever:
itching of the nose or throat
itchy, watery eyes
helps clear nasal passages
helps decongest sinus openings and passages

Purposes

Pain reliever/Fever reducer

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:

blisters
rash
skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Directions

do not use more than directed
adults and children 12 years of age and over:
- take 2 caplets every 4-6 hours
- swallow whole – do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
children under 12 years of age: 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

store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients

benzyl alcohol, crospovidone, magnesium stearate, microcrystalline cellulose, modified corn starch, natural flavor, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, purified water, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Additional Information

KEEP CARTON FOR COMPLETE INFORMATION

Do not use if blister is broken or damaged.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

Questions Or Comments?

1-855-328-5259

Principal Display Panel

NDC 0135-0578-03

FLONASE

HEADACHE &

ALLERGY RELIEF

NEW INGREDIENTS

Acetaminophen 325 mgPain Reliever/Fever Reducer

Chlorpheniramine Maleate 2 mgAntihistamine

Phenylephrine HCI 5 mgNasal Decongestant

FAST RELIEF FROM

Allergy Symptoms
Headache Pain
Nasal Congestion

96CAPLETS

B-0630-778-46 ORG – Front Carton

When Using This Product

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

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 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 Ingredient (in Each Caplet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have

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

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 or other upper respiratory allergies:
sinus congestion and pressure
runny nose and sneezing
minor aches and pains
nasal congestion
headache
temporarily relieves these additional symptoms of hay fever:
itching of the nose or throat
itchy, watery eyes
helps clear nasal passages
helps decongest sinus openings and passages

Purposes

Pain reliever/Fever reducer

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:

blisters
rash
skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Directions

do not use more than directed
adults and children 12 years of age and over:
- take 2 caplets every 4-6 hours
- swallow whole – do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
children under 12 years of age: 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)

store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

Additional Information

KEEP CARTON FOR COMPLETE INFORMATION

Do not use if blister is broken or damaged.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

Questions Or Comments? (Questions or comments?)

1-855-328-5259

Principal Display Panel

NDC 0135-0578-03

FLONASE

HEADACHE &

ALLERGY RELIEF

NEW INGREDIENTS

Acetaminophen 325 mgPain Reliever/Fever Reducer

Chlorpheniramine Maleate 2 mgAntihistamine

Phenylephrine HCI 5 mgNasal Decongestant

FAST RELIEF FROM

Allergy Symptoms
Headache Pain
Nasal Congestion

96CAPLETS

B-0630-778-46 ORG – Front Carton

When Using This Product (When using this product)

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

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 Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen 325 mg

Chlorpheniramine maleate 2 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
high blood pressure
a breathing problem such as emphysema or chronic bronchitis
heart disease
liver disease
thyroid disease
glaucoma
diabetes

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 or other upper respiratory allergies: sinus congestion and pressure runny nose and sneezing minor aches and pains nasal congestion headache temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus openings and passages", "Purposes": "Pain reliever/Fever reducer 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: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away.", "Directions": "do not use more than directed adults and children 12 years of age and over: take 2 caplets every 4-6 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years of age: 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": "store at controlled room temperature 20-25°C (68-77°F)", "Inactive ingredients": "benzyl alcohol, crospovidone, magnesium stearate, microcrystalline cellulose, modified corn starch, natural flavor, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, purified water, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide", "Additional Information": "KEEP CARTON FOR COMPLETE INFORMATION Do not use if blister is broken or damaged. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2022 GSK group of companies or its licensor.", "Questions or comments?": "1-855-328-5259", "Principal Display Panel": "NDC 0135-0578-03 FLONASE HEADACHE & ALLERGY RELIEF NEW INGREDIENTS Acetaminophen 325 mg Pain Reliever/Fever Reducer Chlorpheniramine Maleate 2 mg Antihistamine Phenylephrine HCI 5 mg Nasal Decongestant FAST RELIEF FROM Allergy Symptoms Headache Pain Nasal Congestion 96 CAPLETS B-0630-778-46 ORG – Front Carton", "When using this product": "do not exceed recommended dosage excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery drowsiness may occur", "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 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 ingredient (in each caplet)": "Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg", "Ask a doctor before use if you have": "difficulty in urination due to enlargement of the prostate gland high blood pressure a breathing problem such as emphysema or chronic bronchitis heart disease liver disease thyroid disease glaucoma diabetes", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:56.905984 · Updated: 2026-03-14T23:02:46.668637