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  5. Label Information: Kroger Nighttime Sleep Aid

FDA Label for Kroger Nighttime Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTHER
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. OVERDOSE WARNING
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. OTC - QUESTIONS
    18. PRINCIPAL DISPLAY PANEL

Kroger Nighttime Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Company. 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


Use



for the relief of occasional sleeplessness


Warnings



Warnings


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
■ trouble urinating due to an enlarged prostate gland


Otc - Ask Doctor/Pharmacist



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


When Using This Product



■ avoid alcoholic drinks ■ drowsiness will occur
■ do not drive a motor vehicle or operate machinery


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.


Other



Drug Facts (continued)


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose Warning



In case of overdose, get medical help or contact a
Poison Control Center right away. (1-800-222-1222)


Directions



 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



■ each caplet contains: calcium 23.52 mg
■ store between 20-25°C (68-77°F). Avoid high
humidity. Protect from light.


Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium,
dicalcium phosphate, FD&C Blue #1, FD&C Blue #2,
lecithin, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polyvinyl alcohol, talc, titanium
dioxide


Otc - Questions



Questions or comments? 1-800-632-6900


Principal Display Panel



COMPARE TO the active ingredient of SIMPLY SLEEP ® NIGHTTIME SLEEP AID CAPLETS*

Kroger

NDC 30142-116-01

Nighttime Sleep-Aid

Diphenhydramine HCl, 25mg

Does NOT contain Pain Reliever

For a Restful

Night's Sleep

SAFE, NON-HABIT FORMING

100

MINI-CAPLETS

actual size

*Simply Sleep® is a registered trademark of Johnson & Johnson, New Brunswick, NJ 08933-7001. Johnson & Johnson is not affiliated with The Kroger Co. or this product.


* Please review the disclaimer below.