Nytol

Nytol
SPL v4
SPL
SPL Set ID c81d018a-0170-4396-81e9-2e13a53f868a
Route
ORAL
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
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 Water

Identifiers & Packaging

Pill Appearance
Imprint: N Shape: oval Color: white Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-01
Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Use

For relief of occasional sleeplessness.

Section 42229-5

Drug Facts

Section 51945-4

Nytol® QUICKCAPS®

with Diphenhydramine HCl

NIGHTTIME SLEEP-AID

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

16 CAPLETS

Questions

1-866-255-5203

TAMPER EVIDENT FEATURE:

This product is protected in a sealed blister. Do not use if blister or printed foil is broken or torn.

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
Do Not Use
  • in children over 12 years of age

  • with any other product containing diphenhydramine, even one used on skin
Active Ingredient

(in each caplet)

Diphenhydramine HCI 25 mg

Other Information
  • each caplet contains: calcium 12 mg

  • store below 25ºC (77ºF)
Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silicon dioxide, stearic acid, talc, titanium dioxide, triacetin, water

When Using This Product
  • avoid alcoholic beverages.
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, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Structured Label Content

Use

For relief of occasional sleeplessness.

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

Nytol® QUICKCAPS®

with Diphenhydramine HCl

NIGHTTIME SLEEP-AID

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

16 CAPLETS

Purpose

Nighttime sleep-aid

Questions

1-866-255-5203

TAMPER EVIDENT FEATURE:

This product is protected in a sealed blister. Do not use if blister or printed foil is broken or torn.

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
Do Not Use (Do not use)
  • in children over 12 years of age

  • with any other product containing diphenhydramine, even one used on skin
Active Ingredient (Active ingredient)

(in each caplet)

Diphenhydramine HCI 25 mg

Other Information (Other information)
  • each caplet contains: calcium 12 mg

  • store below 25ºC (77ºF)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silicon dioxide, stearic acid, talc, titanium dioxide, triacetin, water

When Using This Product (When using this product)
  • avoid alcoholic beverages.
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health care professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:45.875623 · Updated: 2026-03-14T23:05:41.137982