Diphenhydramine Hcl 25 Mg

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Calcium Phosphate, Dibasic, Anhydrous Microcrystalline Cellulose Croscarmellose Sodium Silicon Dioxide Magnesium Stearate Polyvinyl Alcohol Talc Titanium Dioxide Polyethylene Glycol D&c Red No. 27 Aluminum Lake Lecithin, Soybean

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-07-31

Medication Information

Purpose

Sleep-aid

Description

Diphenhydramine HCl 25 mg

Uses

for relief of occasional sleeplessness

Section 51945-4

Warnings

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other drugs that cause drowsiness

Directions

do not take more than directed (see overdose warning)
adults and children 12 years of age and over: - take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of age: do not use

Drug Facts

Diphenhydramine HCl 25 mg

Other Information

each caplet contains: calcium 15 mg
store between 20°-25°C (68°-77°F); avoid high humidity
protect from light
read all product information before using

Inactive Ingredients

dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, opadry II

Questions Or Comments?

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Distributed by:

Pioneer Life Sciences

40E Cotters Lane, Suite A

East Brunswick, NJ 08816

When Using This Product

drowsiness will occur
avoid alcoholic drinks
do not drive 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 a serious underlying medical illness.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Overdose Warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask Your Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedative or tranquilizers

Structured Label Content

Uses

for relief of occasional sleeplessness

Section 51945-4 (51945-4)

Purpose

Sleep-aid

Warnings

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other drugs that cause drowsiness

Directions

do not take more than directed (see overdose warning)
adults and children 12 years of age and over: - take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of age: do not use

Drug Facts

Diphenhydramine HCl 25 mg

Other Information (Other information)

each caplet contains: calcium 15 mg
store between 20°-25°C (68°-77°F); avoid high humidity
protect from light
read all product information before using

Inactive Ingredients (Inactive ingredients)

dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, opadry II

Questions Or Comments? (Questions or comments?)

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Distributed by:

Pioneer Life Sciences

40E Cotters Lane, Suite A

East Brunswick, NJ 08816

When Using This Product (When using this product)

drowsiness will occur
avoid alcoholic drinks
do not drive 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 a 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.)

Overdose Warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask Your Doctor Before Use If You Have (Ask your doctor before use if you have)

a breathing problem such as emphysema or chronic bronchitis
glaucoma
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 sedative or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional sleeplessness", "Purpose": "Sleep-aid", "Warnings": "Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness", "Directions": "do not take more than directed (see overdose warning) adults and children 12 years of age and over: - take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years of age: do not use", "Drug Facts": "Diphenhydramine HCl 25 mg", "Other information": "each caplet contains: calcium 15 mg store between 20°-25°C (68°-77°F); avoid high humidity protect from light read all product information before using", "Inactive ingredients": "dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, opadry II", "Questions or comments?": "Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com Distributed by: Pioneer Life Sciences 40E Cotters Lane, Suite A East Brunswick, NJ 08816", "When using this product": "drowsiness will occur avoid alcoholic drinks do not drive 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 a serious underlying medical illness.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "Overdose Warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Ask your doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedative or tranquilizers"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information