DailyMed - ALLERGY PLUS SINUS HEADACHE (2024)

  • Label RSS
  • NDC Code(s): 68210-4190-1
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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

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  • Official Label (Printer Friendly)

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  • Drug Facts

    Active ingredients (in each caplet)

    Acetaminophen 325 mg

    Diphenhydramine HCl 12.5 mg

    Phenylephrine HCl 5 mg

    Purpose

    Pain reliever

    Antihistamine

    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms of hay fever and the common cold:
    • runny nose
    • sneezing
    • headache
    • minor aches and pains
    • nasal congestion
    • temporarily relieves these additional symptoms of hay
    • fever:
    • itching of the nose or throat
    • itchy, watery eyes

  • 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
    • 3 or more alcoholic drinks every day while using this product
    • with other drugs containing acetaminophen

    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.
    • 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

  • Ask a doctor before use if you have

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

  • 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
    • use caution when driving a motor vehicle or operating machinery
    • avoid alcoholic beverages

  • 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

  • PREGNANCY 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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 and over
    • take 2 caplets every 4 hours
    • do not take more than 10 caplets in 24 hours
    • children under 12 years: ask a doctor

  • Other information

    • store at 25oC (77oF); excursions permitted between 15o-30oC (59o-86oF)

  • Inactive Ingredients

    microcrystalline cellulose, pregelatinized starch, croscarmellose sodium,
    polyvinyl pyrrolidone, colloidal silicon dioxide, stearic acid powder, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, tartrazine yellow lake, brilliant blue lake, indigo carmine lake

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

    TAMPER EVIDENT : DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    Spirit Pharmaceuticals, LLC
    Ronkonkoma, NY 11779

    ORIG 05/21

    Made in India

  • label and carton

    label

    DailyMed - ALLERGY PLUS SINUS HEADACHE (3)

    carton

    DailyMed - ALLERGY PLUS SINUS HEADACHE (4)

  • INGREDIENTS AND APPEARANCE
    ALLERGY PLUS SINUS HEADACHE
    acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4190
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
    STARCH, POTATO (UNII: 8I089SAH3T)
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
    PYRROLIDINE (UNII: LJU5627FYV)
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
    STEARIC ACID (UNII: 4ELV7Z65AP)
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
    TALC (UNII: 7SEV7J4R1U)
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code S504
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4190-11 in 1 CARTON11/11/2021
    112 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/11/2021

    Labeler -Spirit Pharmaceuticals LLC(179621011)

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Related Resources

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More Info on this Drug

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ALLERGY PLUS SINUS HEADACHE- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, coated

Number of versions: 3

Published Date (What is this?) Version Files
Dec 11, 2023 4 (current) download
Nov 30, 2022 3 download
Nov 15, 2021 2 download

RxNorm

ALLERGY PLUS SINUS HEADACHE- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, coated

RxCUI RxNorm NAME RxTTY
1 1233575 acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet PSN
2 1233575 acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral Tablet SCD
3 1233575 acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet SY
4 1233575 APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet SY

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ALLERGY PLUS SINUS HEADACHE- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, coated

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NDC Codes

ALLERGY PLUS SINUS HEADACHE- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1 68210-4190-1
DailyMed - ALLERGY PLUS SINUS HEADACHE (2024)
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