Label: OTIS CLAPP VALIHIST- acetaminophen,chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated
MEDIQUE MEDICIDIN D- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated

  • NDC Code(s): 47682-120-13, 47682-120-33, 47682-120-47, 47682-120-64, view more
    47682-120-99, 47682-543-03, 47682-543-99
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 18, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Acetaminophen 325 mg

    Chlorpheniramine Maleate 2 mg

    Phenylephrine Hydrochloride 5 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Antihistamine

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves

    • minor aches and pains
    • headache
    • nasal congestion
    • sinus congestion and pressure
    • runny nose
    • sneezing

    Temporarily

    • reduces fever
    • relieves runny nose and reduces sneezing, itching of the nose and throat and itchy, watery eyes due to hay fever
    • helps clear nasal and/or sinus passages

  • WARNINGS

    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, which is the maximum daily amount
    • 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:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

  • 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.
    • for more than 10 days for pain unless directed by a doctor
    • if you ever had an allergic reaction to this product or any of its ingredients
    • 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 DOCTOR

    Ask a doctor before use if you have

    liver disease
    thyroid disease
    diabetes
    high blood pressure
    heart disease
    glaucoma
    chronic bronchitis or emphysema
    difficulty in urination due to enlargement of the prostate gland

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers
  • WHEN USING

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • may cause drowsiness
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery
  • STOP USE

    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

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-12220. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed

    ​Adults and children (12 years and older): Take 2 tablets every 4 to 6 hours. Do not take more than 10 tablets in 24 hours.

    Children under 12 years: Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • store at room temperature 59º-86ºF (15º-30ºC)
    • tamper evident sealed packets
    • do not use any opened or torn packets
    • avoid excessive heat and humidity
  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • Principal Display Panel - Otis Clapp Valihist Label

    Otis Clapp

    Quality and Integrity Since 1840

    VALIHIST ™

    Decongestant-Antihistamine

    Pain Reliever-Fever Reducer

    Antihistamine- Decongestant

    For Allergies, Colds, Runny Nose

    See Warnings and Directions on Side Panel

    This Package is for Households without Young Children.

    Acetaminophen 325 mg,

    Chlorpheniramine Maleate 2mg

    Phenylephrine HCl 5 mg

    Tear Out Along Perforation To Dispense

    PROFESSIONAL HEALTHCARE

    300 TABLETS (150 PACKETS OF 2)

    Otis

  • Principal Display Panel - Medique Medicidin D Label

    Medique®

    Medicidin-D

    Cold and Allergy Relief

    This Package is for Households without Young Children.

    Pull to Open

    Pain Reliever/ Fever Reducer ● Acetaminophen 325mg

    Antihistamine ● Chlorpheniramine Maleate 2mg

    Nasal Decongestant ● Phenylephrine HCl 5mg

    100Tablets

    (50 x 2)

    Tamper Evident Unit Dose Packets

    Medique

  • INGREDIENTS AND APPEARANCE
    OTIS CLAPP VALIHIST 
    acetaminophen,chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-543
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSPOVIDONE (UNII: 68401960MK)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size11mm
    FlavorImprint Code AZ;275
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-543-03150 in 1 BOX12/30/2008
    1NDC:47682-543-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-543-992 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/30/2008
    MEDIQUE MEDICIDIN D 
    acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSPOVIDONE (UNII: 68401960MK)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size11mm
    FlavorImprint Code AZ;275
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-120-6412 in 1 BOX12/30/2008
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-120-3350 in 1 BOX12/30/2008
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-120-47100 in 1 BOX12/30/2008
    32 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-120-13250 in 1 BOX12/30/2008
    4NDC:47682-120-992 in 1 PACKET; Type 0: Not a Combination Product
    5NDC:47682-120-992 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/30/2008
    Labeler - Unifirst First Aid Corporation (832947092)
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