Label: FLONASE HEADACHE AND ALLERGY RELIEF- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
- NDC Code(s): 0135-0578-01, 0135-0578-02, 0135-0578-03
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 8, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purposes
-
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
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
- more than 4,000 mg of acetaminophen in 24 hours
- Directions
- Other information
-
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?
- Additional Information
-
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
-
INGREDIENTS AND APPEARANCE
FLONASE HEADACHE AND ALLERGY RELIEF
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0578 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor Imprint Code FRH Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0578-01 1 in 1 CARTON 03/10/2022 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0135-0578-02 4 in 1 CARTON 03/10/2022 2 48 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0135-0578-03 8 in 1 CARTON 03/10/2022 3 96 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/10/2022 Labeler - Haleon US Holdings LLC (079944263)
