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  5. Label Information: Diphenhydramine Oral Liquid

FDA Label for Diphenhydramine Oral Liquid

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT IN EACH 5 ML ( IN ONE TEASPOONFUL)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Diphenhydramine Oral Liquid Product Label

The following document was submitted to the FDA by the labeler of this product Rising Health, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Active Ingredient In Each 5 Ml ( In One Teaspoonful)



Diphenhydramine HCl, 12.5 mg


Purpose



Antihistamine


Uses



temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

    • temporarily relieves these symptoms due to the common cold:

    • runny nose
    • sneezing

Do Not Use



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

Ask A Doctor Before Use If You Have



  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis.
  • a sodium-restricted diet

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.


When Using This Product



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

If Pregnant Or Breast-Feeding,



ask a health professional before use


Keep Out Of Reach Of Children.



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


Directions



  • take every 4-6 hours
  • Do not use more than 6 dose in 24 hours
    • adults and children 12 years of age and over2 to 4 teaspoonfuls (25 to 50 mg)
    children 6 to under 12 years of age1 to 2 teaspoonfuls (12.5 to 25 mg)
    children under 6 yearsask a doctor


Other Information



  • store at room temperature 15° - 30°C (59° - 86°F)
  • protect from freezing
  • protect from light
  • each teaspoon (5 mL) contains: sodium 8 mg

    • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.


Inactive Ingredients



cherry flavor, citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.


Questions Or Comments?



1-844-474-7464


Principal Display Panel



Rising Health, LLC

NDC 57237-305-12

Diphenhydramine Hcl 12.5 mg/5 mL Oral Solution

4 fl oz (118 mL)

diphenhydramine-label - diphenhydramine label

diphenhydramine-label - diphenhydramine label


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