Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Silicon Dioxide Starch, Corn Fd&c Blue No. 1 Calcium Phosphate, Dibasic, Anhydrous Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: PH25 Shape: capsule Color: blue Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2019-07-02

Medication Information

Purpose

Nighttime sleep aid

Description

Diphenhydramine HCl 25 mg

Uses

helps reduce difficulty falling asleep

Section 51945-4

PHARBEST

NDC 73057-358-06

Manufactured in the USA

Safe, Non-habit forming

Sleep Aid

*Compare to the active ingredient in Sominex ^®

Diphenhydramine HCl 25 mg

Nighttime Sleep Aid

50 CAPLETS

Directions

adults and children 12 years and over

take 2 caplets at bedtime if needed, or as directed by your doctor

Do Not Use

in children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other antihistamines

Other Information

each caplet contains: calcium 15 mg
store at 20-25 ^oC (68-77 ^oF)

Inactive Ingredients

colloidal silicon dioxide, corn startch, FD&C blue #1, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions Or Comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product

avoid alcoholic drinks
use caution 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.

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

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses

helps reduce difficulty falling asleep

Section 51945-4 (51945-4)

PHARBEST

NDC 73057-358-06

Manufactured in the USA

Safe, Non-habit forming

Sleep Aid

*Compare to the active ingredient in Sominex ^®

Diphenhydramine HCl 25 mg

Nighttime Sleep Aid

50 CAPLETS

Purpose

Nighttime sleep aid

Directions

adults and children 12 years and over

take 2 caplets at bedtime if needed, or as directed by your doctor

Do Not Use (Do not use)

in children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other antihistamines

Other Information (Other information)

each caplet contains: calcium 15 mg
store at 20-25 ^oC (68-77 ^oF)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, corn startch, FD&C blue #1, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product (When using this product)

avoid alcoholic drinks
use caution when driving a motor vehicle or operating machinery

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 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 right away (1-800-222-1222).

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg

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

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

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

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Raw Label Data

All Sections (JSON)

{"Uses": "helps reduce difficulty falling asleep", "51945-4": "PHARBEST NDC 73057-358-06 Manufactured in the USA Safe, Non-habit forming Sleep Aid *Compare to the active ingredient in Sominex ® Diphenhydramine HCl 25 mg Nighttime Sleep Aid 50 CAPLETS", "Purpose": "Nighttime sleep aid", "Directions": " adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by your doctor", "Do not use": "in children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other antihistamines", "Other information": "each caplet contains: calcium 15 mg store at 20-25 o C (68-77 o F)", "Inactive ingredients": "colloidal silicon dioxide, corn startch, FD&C blue #1, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide", "Questions or comments?": "(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)", "When using this product": "avoid alcoholic drinks use caution 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.": "In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "Active ingredient (in each caplet)": "Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information