diphenhydramine hydrochloride soft gelatin capsules

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (50 mg)

Inactive Ingredients

polyethylene glycol 400 propylene glycol gelatin sorbitol water fd&c blue no. 1

Identifiers & Packaging

Pill Appearance

Imprint: 293 Shape: oval Color: blue Size: 18 mm Score: 1

Marketing Status

otc monograph final active Since 2010-06-01

Medication Information

Uses

For relief occasional sleeplessness

Purpose

Nighttime Sleep aid

Inactive Ingredients

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

In case of overdose,get medical help or contact a poison control center right away.

Section 50567-7

When using this product avoid alcoholic drinks

Section 50568-5

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

Section 53414-9

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

Direction

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

Do Not Use

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

Stop Use and Ask Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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

Active Ingredients (in Each Liquicap)

Diphenhydramine HCl 50 mg

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

Structured Label Content

Uses

For relief occasional sleeplessness

Purpose

Nighttime Sleep aid

Inactive Ingredients (Inactive ingredients)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose,get medical help or contact a poison control center right away.

Section 50567-7 (50567-7)

When using this product avoid alcoholic drinks

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

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

Direction

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

Do Not Use (Do not use)

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

Stop Use and Ask Doctor If (Stop use and ask doctor if)

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Ask A Doctor Before Use If You Have (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

Active Ingredients (in Each Liquicap) (Active ingredients (in each LiquiCap))

Diphenhydramine HCl 50 mg

Principal Display Panel 50 Mg Shipper Label (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

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For relief occasional sleeplessness", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children . In case of overdose,get medical help or contact a poison control center right away.", "50567-7": "When using this product avoid alcoholic drinks", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use", "Purpose": "Nighttime Sleep aid", "Direction": "adults and children 12 years of age and older -1 softgel (50mg) at bedtime if needed; or as directed by doctor", "Do not use": "for children under 12 years of age with any other product containing Diphenhydramine, even one used on skin", "Inactive ingredients": "PEG – 400, Propylene Glycol USP , Gelatin , Sorbitol, FD & C Blue No.1 IH, Purified water", "Stop use and ask doctor if": "sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.", "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", "Active ingredients (in each LiquiCap)": "Diphenhydramine HCl 50 mg", "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"}

diphenhydramine hydrochloride soft gelatin capsules

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information