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  5. Label Information: Diphenhydramine Hydrochloride

FDA Label for Diphenhydramine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS (IN EACH LIQUICAP)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. STOP USE AND ASK DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL - 50 MG SHIPPER LABEL

Diphenhydramine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals,llc. 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.

Other



Drug Facts


Active Ingredients (In Each Liquicap)



Diphenhydramine HCl 50 mg


Purpose



Nighttime Sleep aid


Uses



For relief occasional sleeplessness


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



  • Glaucoma
  • trouble urinating due to enlarged postage gland
  • a breathing problem such as emphysema or chronic bronchitis

Otc - Ask Doctor/Pharmacist



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


Otc - When Using



When using this product avoid alcoholic drinks


Stop Use And Ask 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.


Direction



adults and children 12 years of age and older -1 softgel (50mg) at bedtime if needed; or as directed by doctor


Inactive Ingredients



PEG – 400, Propylene Glycol USP , Gelatin , Sorbitol, FD & C Blue No.1 IH, Purified water


Principal Display Panel - 50 Mg Shipper Label



Diphenhydramine Hydrochloride Soft Gelatin Capsules

Each soft gelatin capsule contains:
Diphenhydramine Hydrochloride USP 50 mg

LOT NO :

MFG DATE :

EXP. DATE :

NDC NO : 68210-1510-4

QUANTITY : 1000 × 4 Capsules

GROSS WT. :

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS BULK SHIPMENT IS INTENDED FOR FURTHER PACKAGING PROCESS ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FD & C ACT AND REGULATIONS THEREUNDER.

MANUFACTURED BY:
Marksans Pharma Ltd
VERNA, GOA-403722,
INDIA.
CODE : GO/DRUGS/515

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

OLIL058

PRINCIPAL DISPLAY PANEL - 50 mg Shipper Label - diphenhydramine 01

PRINCIPAL DISPLAY PANEL - 50 mg Shipper Label - diphenhydramine 01


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