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Diphenhydramine hydrochloride - Medication Information

Product NDC Code 73629-007
Drug Name

Diphenhydramine hydrochloride

Type Brand
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Diphenhydramine hydrochloride 25 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 1049909
Application Number M010
Labeler Name AMZ789 LLC
Packages
Package NDC Code Description
73629-007-22 220 capsule, liquid filled in 1 bottle (73629-007-22)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Diphenhydramine HCl 25 mg Diphenhydramine HCl 25 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Diphenhydramine HCl 25 mg

Dosage forms and strengths

Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.
take only one dose per day (24 hours) - see Overdose warning adults & Children 12 yrs & over One dose = TWO 25mg softgels (50mg) at bedtime if needed or as directed by a doctor
adults & Children 12 yrs & overOne dose = TWO 25mg softgels (50mg)at bedtime if needed or as directed by a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Purpose

Information about the drug product’s indications for use.
Nighttime sleep-aid for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Spl product data elements

Usually a list of ingredients in a drug product.
DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride capsule, liquid filled POLYETHYLENE GLYCOL, UNSPECIFIED DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C RED NO. 40 GLYCERIN GELATIN SORBITOL FD&C BLUE NO. 1 WATER PC11 Oblong

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Display Panel

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
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

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
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

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery

Pregnancy or breast feeding

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

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings 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 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 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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API