Diphenhydramine Hydrochloride 25 Mg Capsule, Liquid Filled

Diphenhydramine Hydrochloride 25 Mg Capsule, Liquid Filled
SPL v5
SPL
SPL Set ID 7830ce18-908a-4f86-a238-8c31cfe47ce6
Route
ORAL
Published
Effective Date 2019-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol, Unspecified Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: PC11 Shape: capsule Color: purple Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-15

Description

Drug Facts

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. Overdose warning:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers or any other sleep aid

Section 53414-9

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

Directions
  • take only one dose per day (24 hours) -  see Overdose warning

adults & children

12 yrs & over

                     One dose = TWO 25 mg softgels (50 mg)

                     at bedtime if needed or as directed by a doctor

Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
  • do not use with NyQuil
Other Information
  • store at room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat above 40°C (104°F) and high humidity
  • protect from light
Inactive Ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Wuhan, Hubei

430206, China

When Using This Product
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
Active Ingredient (in Each Capsule)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease
Principal Display Panel Shipping Label

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 25 mg

Quantity : 20000 Capsules

NDC. No : 53345-002-02

IMPORTANT:

Inspect immediate upon receipt.

This is a bulk shipment intended for further processing only.

Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"


Structured Label Content

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. Overdose warning:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers or any other sleep aid

Section 53414-9 (53414-9)

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

Purpose

Nighttime sleep-aid

Directions
  • take only one dose per day (24 hours) -  see Overdose warning

adults & children

12 yrs & over

                     One dose = TWO 25 mg softgels (50 mg)

                     at bedtime if needed or as directed by a 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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
  • do not use with NyQuil
Other Information (Other information)
  • store at room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat above 40°C (104°F) and high humidity
  • protect from light
Inactive Ingredients (Inactive ingredients)

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Wuhan, Hubei

430206, China

When Using This Product (When using this product)
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease
Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 25 mg

Quantity : 20000 Capsules

NDC. No : 53345-002-02

IMPORTANT:

Inspect immediate upon receipt.

This is a bulk shipment intended for further processing only.

Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"


Advanced Ingredient Data


Raw Label Data

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