Sign In

Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"

You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.

View Generic:
View Brand:

Nytol - Medication Information

Product NDC Code 63029-211
Drug Name

Nytol

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,
1092416
Application Number part338
Labeler Name Medtech Products Inc.
Packages
Package NDC Code Description
63029-211-01 4 blister pack in 1 box (63029-211-01) / 8 tablet in 1 blister pack
63029-211-02 2 blister pack in 1 box (63029-211-02) / 8 tablet in 1 blister pack
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient 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 adults and children 12 years of age and over: take 2 caplets (50 mg) at bedtime if needed, 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 crosscarmellose sodium, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, tracetin

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.
Use relieves 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.
Nytol Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS HYPROMELLOSE, UNSPECIFIED LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN N

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 Nytol QuickCaps with Diphenhydramine HCl Nighttime Sleep-Aid 32 caplets Nytol QuickCaps 32 count carton PRINCIPAL DISPLAY PANEL Nytol QuickCaps with Diphenhydramine HCl Nighttime Sleep-Aid 16 caplets Nytol QuickCaps 16 count carton

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.
Other information each caplot contains: c alcium 12 mg store at 20°-25°C (68°-77°F)

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 trouble urinating due to an enlarged prostate gland glaucoma

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

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, gret medical help or contact a Poison Control center (1-800-222-1222) 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.
When using this product avoid alcoholic beverages be careful when driving a moter vehicle or operating machinery

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health care 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 Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other antihistamines Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma When using this product avoid alcoholic beverages be careful when driving a moter 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 care professional before use. Keep out of reach of children. In case of overdose, gret medical help or contact a Poison Control center (1-800-222-1222) 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