diphenhydramine hcl tablets 25 mg blue

SPL v1

SPL

SPL Set ID d46fff27-1a0f-42b8-b247-d2d9d4d17ac7

Route

oral

Published

Effective Date 2010-02-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (25 mg)

Inactive Ingredients

cellulose, microcrystalline silicon dioxide anhydrous dibasic calcium phosphate croscarmellose sodium magnesium stearate polyethylene glycol polyvinyl alcohol titanium dioxide water d&c red no. 27

Identifiers & Packaging

Pill Appearance

Imprint: S5 Shape: oval Color: blue Size: 10 mm Score: 1

Marketing Status

otc monograph final active Since 2010-03-01

Purpose

Nighttime sleep aid

Description

Drug Facts

Medication Information

Purpose

Nighttime sleep aid

Dosage and Administration

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 blister 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

Description

Drug Facts

Use

relief of occasional sleeplessness

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50567-7

When using this product

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

Section 50568-5

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

Section 50569-3

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

Section 50570-1

Do not use

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

Section 53414-9

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

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

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"

Structured Label Content

Purpose

Nighttime sleep aid

Dosage and Administration (34068-7)

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 (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Use

relief of occasional sleeplessness

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product

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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use

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

Section 53414-9 (53414-9)

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

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg

Principal Display Panel 25 Mg Label (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

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"

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27", "unii": "2LRS185U6K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "relief of occasional sleeplessness", "34068-7": "Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50566-9": "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.", "50567-7": "When using this product avoid alcoholic drinks drowsiness will occur do not drive a motor vehicle or operate machinery", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "50569-3": "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", "50570-1": "Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Nighttime sleep aid", "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 blister 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", "Active ingredient (in each caplet)": "Diphenhydramine HCl 25 mg", "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""}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:00.939218 · Updated: 2026-03-14T22:52:19.062647