FLONASE Headache and Allergy Relief ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHRINE HCL HALEON US HOLDINGS LLC FDA Approved 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
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg
Inactive Ingredients
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
Strengths
325 mg 2 mg 5 mg
Treats Conditions
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
Pill Appearance
Shape: oval Color: white Imprint: FRH

Identifiers & Packaging

Container Type BOX
UNII
362O9ITL9D V1Q0O9OJ9Z 04JA59TNSJ
Packaging

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 B-0630-778-46 Flonase 96 Caplets

Package Descriptions
  • 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 B-0630-778-46 Flonase 96 Caplets

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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. 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 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 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.
Purpose

Purposes Pain reliever/Fever reducer Antihistamine Nasal decongestant

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

When Using

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 & Ask a Doctor

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.

Keep Out of Reach of Children

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.

Storage & Handling

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

Questions

Questions or comments? 1-855-328-5259


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