1. Home
  2. Labeler Index
  3. Gobrands, Inc
  4. 82501-1578
  5. Label Information: Diphenhydramine Hydrochloride

FDA Label for Diphenhydramine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Gobrands, 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 Softgel)



Diphenhydramine HCl 25 mg


Purpose



Nighttime sleep-aid


Uses



● for the relief of occasional sleeplessness ● reduces time to fall asleep if you have difficulty falling asleep


Warnings




Otc - Do Not Use



Do not use ● for children under 12 years of age ● with any other product containing diphenhydramine, even one used on skin


Otc - Ask Doctor



Ask a doctor before use if you have ● a breathing problem such as asthma, emphysema, or chronic bronchitis ● glaucoma ● difficulty in urination due to enlargement of the prostate gland


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use ifyou are taking sedatives, tranquilizers or any other sleep aid


Otc - Stop Use



Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.


Otc - Pregnancy Or Breast Feeding



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


Otc - 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. (1-800-222-1222)


Directions



take only one dose per day (24 hours)

adults & children 12 years & overOne dose = TWO 25 mg softgels (50 mg) at
bed time if needed or as directed by a doctor
children under 12 yearsdo not use


Other Information



● store at 20-25° C (68-77° F) ● avoid excessive heat above 40° C (104° F) and high humidity
● Protect from light


Inactive Ingredients



FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide.


Questions Or Comments?



1-888-333-9792


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL


* Please review the disclaimer below.