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  5. Label Information: Diphenhydramine Hydrochloride

FDA Label for Diphenhydramine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

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

Diphenhydramine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. 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.

Active Ingredient (In Each 5 Ml Teaspoonful)



Diphenhydramine HCl 12.5 mg


Purpose



Antihistamine


Uses



  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • temporarily relieves these symptoms due to the common cold:
  • sneezing
  • runny nose

Do Not Use



  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask A Doctor Before Use If You Have



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

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


When Using This Product



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

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



  • if needed, take every 4-6 hours
  • do not take more than 6 doses in 24 hours

    • children under 4

    years of age    		do not use

    children 4 to under 6

    years of age    		do not use unless directed by a doctor

    children 6 to under

    12 years of age

    1 to 2 teaspoonfuls

    (12.5 mg to 25 mg)

    adults and children

    12 years of age

    and over

    2 to 4 teaspoonfuls

    (25 mg to 50 mg)

Other Information



  • each teaspoonful contains: sodium 15 mg
  • store at 20°-25°C (68°-77°F)

Inactive Ingredients



citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol


Questions Or Comments?



1-800-719-9260


Principal Display Panel




Diphenhydramine Hydrochloride

12.5 mg/ 5 mL

NDC 54868-5622-0

image of package label - 5622

image of package label - 5622


Relieves:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

See New Warning and Dosing Directions

Cherry Flavored

4 fl oz (118 mL)

Alcohol Free



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

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