1. Home
  2. Labeler Index
  3. Geri-care Pharmaceutical Corp
  4. 57896-785
  5. Label Information: Nighttime Sleep-aid

FDA Label for Nighttime Sleep-aid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. PACKAGE LABEL

Nighttime Sleep-aid Product Label

The following document was submitted to the FDA by the labeler of this product Geri-care Pharmaceutical Corp. 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 Caplet)



Diphenhydramine Hydrochloride 25mg


Purpose



Nighttime Sleep-aid


Uses



  • relieves occasional sleeplessness

Warnings



Do not use

• in children under 12 years

• with any other product containing diphenhydramine, including one used

on skin


Ask a doctor before use if you have

• a breathing problem such as emphysema, asthma, or chronic bronchitis

• glaucoma

• trouble urinating due to an enlarged prostate gland


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


When using this produc t

• avoid alcoholic beverages

• drowsiness will occur

• avoid driving a motor vehicle or operating machinery


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

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



Directions



• adults and children 12 years and over: take two caplets at bedtime if needed, or as directed by a doctor

• do not exceed recommended dose


Other Information



  • each caplet contains: calcium 85mg
  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)

Inactive Ingredients



calcium phosphate, croscarmellose sodium, magnesium stearate,

microcrystalline cellulose, silica.


Package Label



NDC 57896-785-72

Health Star

the sensible choice for price and health


NightTime Sleep-Aid

with Diphenhydramine HCl


72 Caplets

25 mg each

Compare to active ingredient in Nytol

Night time sleep aid label - L785 72 HST

Night time sleep aid label - L785 72 HST


* Please review the disclaimer below.