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Allergy relief - Medication Information

Product NDC Code 36800-436
Drug Name

Allergy relief

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 part341
Labeler Name Topco Associates LLC
Packages
Package NDC Code Description
36800-436-24 100 capsule, liquid filled in 1 bottle (36800-436-24)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each softgel) 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.
Directions take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years and over 1 to 2 softgels children 6 to under 12 years 1 softgel children under 6 years do not use this product in children under 6 years of age
adults and children 12 years and over 1 to 2 softgels
children 6 to under 12 years 1 softgel
children under 6 years do not use this product in children under 6 years of age

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution and white 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.
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Purpose

Information about the drug product’s indications for use.
Purpose Antihistamine

Spl product data elements

Usually a list of ingredients in a drug product.
Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE GELATIN GLYCERIN POLYETHYLENE GLYCOL WATER SORBITOL SORBITAN clear oblong PC4

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.
PRINCIPAL DISPLAY PANEL Allergy Relief Diphenhydramine HCl 25 mg 100 softgels NDC 36800-436-24 *Compare to the active ingredient in Benadryl ® Dye-Free Allergy Liqui-Gels ® principal display panel drug facts

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

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 glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis

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

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 to make a child sleepy with any other product containing diphenhydramine, even one used on skin

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. (1-800-222-1222)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call toll free: 1-888-423-0136

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 marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children

Pregnancy or breast feeding

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

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at room temperature 15°-30°C (59°-86°F) protect from heat, humidity, and light

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 Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children 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. (1-800-222-1222)

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