FDA Label for Equate Nighttime Sleep Aid

View Indications, Usage & Precautions

Equate Nighttime Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Walmart 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 Caplet)



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

Do Not Use



  • •for children under 12 years of age
  • •with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have



  • •a breathing problem such as emphysema or chronic bronchitis
  • •glaucoma
  • •difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


When Using This Product



avoid alcoholic beverages


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.


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 (1-800-222-1222).


Directions



  • •take only one dose (2 caplets) per day (24 hours)
  • adults and children 12 years and over

    take 2 caplets at bedtime if needed, or as directed by a doctor

    children under 12 years

    do not use


Other Information



  • •store at 20-25°C (68-77°F)
  • do not use if printed seal under cap is broken or missing

Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, pregelatinized starch, stearic acid, talc, titanium dioxide


Questions Or Comments?



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Principal Display Panel



equate™

Compare to Vicks® ZzzQuil® active ingredient

NIGHTTIME

Sleep-Aid

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid

Actual Size

• Non-habit forming

• Not for treating cold and flu

25 mg EACH

365 CAPLETS


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