FDA Label for Flonase Headache And Allergy Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSES
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- ADDITIONAL INFORMATION
- PRINCIPAL DISPLAY PANEL
Flonase Headache And Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Caplet)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg
Purposes
Pain reliever/Fever reducer
Antihistamine
Nasal decongestant
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
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
• blisters• rash• skin reddening
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms
may include:
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
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.
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
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
Questions Or Comments?
1-855-328-5259
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.
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
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