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DIPHENHYDRAMINE HYDROCHLORIDE (diphenhydramine hydrochloride 25 mg) Dailymed


Generic: diphenhydramine hydrochloride is used for the treatment of Anxiety Disorders Infant, Newborn Infant, Premature Sleep Initiation and Maintenance Disorders Lactation Motion Sickness Nausea Rhinitis, Allergic, Perennial Sneezing Status Asthmaticus Urticaria


IMPRINT: S5     SHAPE: oval
    COLOR: blue

All Imprints

diphenhydramine hydrochloride tablet, film coated - s5 oval blue

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Drug Facts

Active Ingredient (in Each Caplet)


Diphenhydramine HCl 25 mg

Purpose


Nighttime sleep aid

Use


relief of occasional sleeplessness

Warnings


OTC - DO NOT USE SECTION


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

OTC - ASK DOCTOR SECTION


Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION


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

OTC - WHEN USING SECTION


When using this product
  • avoid alcoholic drinks
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

OTC - STOP USE SECTION


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 SECTION


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children.

Dosage & Administration Section


Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away.

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 20 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or buler unit is broken
  • see side panel for lot number and expiration date

Inactive Ingredients


carnauba wax, cellulose, croscarmellose sodium dibasic calcium phosphate, FD&C blue #1, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, titanium dioxide

Principal Display Panel - 25 Mg Label


DIPHENHYDRAMINE HCL TABLETS 25 mg BLUE Each Film coated Tablet Contains: DIPHENHYDRAMINE HCL 25 MG
Lot No : Jar No. :
MFG. DATE : Quantity : 100,000 Tablets
Exp. Date : NDC. No : 65437-037-10

WARNING : KEEP OUT OF THE REACH OF CHILDREN STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C) PROTECT FROM LIGHT, MOISTURE AND FREEZING THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER

MANUFACTURED BY: MANUFACTURED CODE No Guj/Drugs/G/1362 LABELER CODE # 14803

MANUFACTURED FOR: HIMPRIT PHARMACHEM PVT. LTD "LAKULISH", R.V.DESAI ROAD, NEXT TO NAVAPURA POLICE STATION BARODA, INDIA – 390 001

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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