Label: SEVERE ALLERGY AND SINUS HEADACHE- acetaminophen, diphenhydramine hydrochloride and phenylephrine hydrochloride tablet 

  • NDC Code(s): 11822-0543-1, 11822-0543-9
  • Packager: Rite Aid
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/11

If you are a consumer or patient please visit this version.

  • Inactive ingredients

    (in each caplet)

    Acetaminophen 325 mg

    Diphenhydramine HCl 25 mg

    Phenylephrine HCl 5 mg

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  • Purpose

    Pain reliever

    Antihistamine

    Nasal decongestant

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  • Uses

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

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 12 caplets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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.
    • with any other product containing diphenhydramine, even one used on skin
    • 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.

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    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
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

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

    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.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    • do not use more than directed (see overdose warning)
    • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • do not take more than 12 caplets in 24 hours
    • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
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  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    corn starch, crospovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin

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  • Questions or comments?

    1-800-426-9391

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  • Product Packaging

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    RITE

    AID®

    PHARMACY

    Compare to the active

    ingredients in Benadryl® Severe

    Allergy Plus Sinus Headache*

    See New Warnings Information

    Maximum Strength

    Severe Allergy†

    Plus SINUS HEADACHE

    Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl

    Pain Reliever, Antihistamine, Nasal Decongestant

    Relieves Sinus Headache, Sneezing, Runny Nose, Itchy Throat,

    Sinus Congestion, Sinus Pressure & Itchy, Watery Eyes

    Upper Respiratory Allergies Only

    20 CAPLETS

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

    50844          ORG051054309

    DISTRIBUTED BY:

    Rite Aid

    30 Hunter Lane.

    Camp Hill, PA 17011

    Product Packaging

    Product Packaging

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  • INGREDIENTS AND APPEARANCE
    SEVERE ALLERGY AND SINUS HEADACHE 
    acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0543
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    CROSPOVIDONE  
    CROSCARMELLOSE SODIUM  
    FD&C BLUE NO. 1  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOL  
    POVIDONE  
    SILICON DIOXIDE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    TRIACETIN  
    Product Characteristics
    Color BLUE Score no score
    Shape CAPSULE Size 16mm
    Flavor Imprint Code 44;543
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0543-9 1 in 1 CARTON
    1 20 in 1 BLISTER PACK
    2 NDC:11822-0543-1 1 in 1 CARTON
    2 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 06/27/2007
    Labeler - Rite Aid (014578892)
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