Diphenhydramine Hydrochloride
FDA Label NDC 68210-1510

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals,llc for the product Diphenhydramine Hydrochloride (NDC 68210-1510). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients (in each liquicap), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Principal Display Panel (50 mg Shipper Label)

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