DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD. FDA Approved Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
FunFoxMeds box
Route
ORAL
Applications
M010
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each softgel) Diphenhydramine HCl 25 mg
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
Strengths
25 mg
Quantities
20000 capsules
Treats Conditions
Uses For The Relief Of Occasional Sleeplessness Reduces Time To Fall Asleep If You Have Difficulty Falling Asleep
Pill Appearance
Shape: capsule Color: purple Imprint: 654

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
TC2D6JAD40
Packaging

PRINCIPAL DISPLAY PANEL - Shipping Label DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 25 mg Quantity : 20000 Capsules NDC. No : 53345-027-01 IMPORTANT: Inspect immediately upon receipt. This is a bulk shipment, intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. Store at 15-30°C (59-86°F) CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING" Shipping Label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - Shipping Label DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 25 mg Quantity : 20000 Capsules NDC. No : 53345-027-01 IMPORTANT: Inspect immediately upon receipt. This is a bulk shipment, intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. Store at 15-30°C (59-86°F) CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING" Shipping Label

Overview

Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Indications & Usage

Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Dosage & Administration

Directions take only one dose per day (24 hours) - see Overdose warning adults & children 12 yrs of age & over ONE dose = TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor

Warnings & Precautions
Warnings 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 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 Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid 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 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. If pregnant or breast-feeding, ask a health professional before use. 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.
Purpose

Purpose Nighttime sleep-aid

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

When Using

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

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

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.

Storage & Handling

Other information store at 15°-30°C (59°-86°F) avoid excessive heat above 40°C (104°F) and high humidity protect from light


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