Label: SILPHEN - diphenhydramine hydrochloride syrup

  • NDC Code(s): 54838-154-40, 54838-154-70, 54838-154-80
  • Packager: Silarx Pharmaceutical, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 06/14

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

  • ACTIVE INGREDIENT

    Active Ingredient: Diphenhydramine hydrochloride 12.5 mg (in each 5 mL(teaspoonful)(TSP))

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  • PURPOSE

    Purpose: Antitussive

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  • Uses

    temporarily relieves coughs due to cold or bronchial irritation

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  • Warnings

    Do not use with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    •  cough is accompanied by excessive phlegm (mucus)
    • breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
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  • Stop use and ask a doctor

    if symptoms last for more than 1 week or recurred or accompanied by fever, rash, headache

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  • Ask a doctor or pharmacist before use

    if you are  taking tranquilizers or sedatives

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  • When using this product

    • you may get drowsy
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children
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  • PREGNANCY

    If pregnant or breast-feeding

    •  ask a health professional before use.

    Keep out of reach of children.

    • In case of accidental overdose, get medical help or contact a Poison Control Center right away.
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    Do not take more than six doses

    Adults and children over 12 years
    2 teaspoonfuls (TSP) every 4 hours
    children under 12 years
    DO NOT USE
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  • Other information

    • Store below 20°-25°C (68°-77°F)
    •  Protect from freezing.
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  • Inactive ingredients:

    Alcohol 5%, ammonium chloride, citric acid, D&C red no. 33, FD&C red no. 40, menthol, methylparaben, propylene glycol, propylparaben, sodium citrate, strawberry flavor, sucrose, water

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  • QUESTIONS

    Questions: 888-974-5279

    Manufactured by:

    Sliarx Pharmaceutical, Inc
    1033 Stoneleigh Ave.
    Carmel, NY 10512 USA.

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  • INGREDIENTS AND APPEARANCE
    SILPHEN 
    diphenhydramine hydrochloride syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54838-154
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Diphenhydramine hydrochloride (Diphenhydramine) Diphenhydramine hydrochloride 12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Alcohol  
    ammonium chloride  
    anhydrous citric acid  
    D&C red no. 33  
    FD&C red no. 40  
    menthol  
    methylparaben  
    propylene glycol  
    propylparaben  
    sodium citrate  
    sucrose  
    water  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor STRAWBERRY (Strawberry Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54838-154-40 118 mL in 1 BOTTLE, PLASTIC
    2 NDC:54838-154-70 237 mL in 1 BOTTLE, PLASTIC
    3 NDC:54838-154-80 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 12/03/1993
    Labeler - Silarx Pharmaceutical, Inc (161630033)
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