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Dormmy-lon - Medication Information

Product NDC Code 83164-000
Drug Name

Dormmy-lon

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 TABLET
RxCUI drug identifier 1049630
Application Number M010
Labeler Name Haendel Farma, S.A. de C.V.
Packages
Package NDC Code Description
83164-000-01 1 bottle in 1 box (83164-000-01) / 60 tablet in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient (in each pill) Diphenhydramine hydrochloride 25 mg Purpose Nighttime sleep-aid

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.
Directions Take only one dose per day (24 hours) Adults and children 12 years & over 2 pills or as directed by a doctor children under 12 years Do not use
Adults and children 12 years & over 2 pills or as directed by a doctor
children under 12 years Do not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Lactose, P.V.P., Starch, Blue Color FD&C # 1, Microcrystalline Cellulose, Croscarmellose, Sodium, Magnesium Stearate

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.
Uses: Helps to reduce difficulty in falling sleep For the relief of occasional sleeplessness

Purpose

Information about the drug product’s indications for use.
Purpose Nighttime sleep-aid

Spl product data elements

Usually a list of ingredients in a drug product.
DORMMY-LON DIPHENHYDRAMINE HYDROCHLORIDE SODIUM MAGNESIUM STEARATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE LACTOSE, UNSPECIFIED FORM POVIDONE, UNSPECIFIED FD&C BLUE NO. 1 MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE Q

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.
Package Labeling: Outer Package0 Inner Package0

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Other information Store at 68° - 77 °F (20-25 °C) Protect from light. See printed for lot number and exp. date.

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have: A breathing problem such as emphysema or chronic bronchitis Glaucoma Difficulty in urination due to an enlarged prostate gland Ask a doctor or pharmacist before use it if you are taking sedatives, tranquilizers or any other drugs

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.
Do not use For children under 12 years of age With any other product containing diphehydramine

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. 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 continuosly for more than 2 weeks, In sommia 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.
When using this product Avoid alcoholic beverages

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 Ask a doctor before use if you have: A breathing problem such as emphysema or chronic bronchitis Glaucoma Difficulty in urination due to an enlarged prostate gland Do not use For children under 12 years of age With any other product containing diphehydramine Ask a doctor or pharmacist before use it if you are taking sedatives, tranquilizers or any other drugs When using this product Avoid alcoholic beverages Stop use and ask a doctor if sleeplessness persists continuosly for more than 2 weeks, In sommia 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. 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