SPL v2
SPL
SPL Set ID a9637ec7-9a71-4023-e053-2995a90ad0da
Route
ORAL
Published
Effective Date 2020-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Lecithin, Soybean Cellulose, Microcrystalline Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Silicon Dioxide Magnesium Stearate Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide Polyethylene Glycol, Unspecified D&c Red No. 27 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: S5 Shape: capsule Color: blue Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-06-29

Description

Diphenhydramine Hcl 25mg

Purpose

Sleep-aid


Medication Information

Purpose

Sleep-aid

Description

Diphenhydramine Hcl 25mg

Uses:

for relief of occasional sleeplessness

Pregnancy

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

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

Ask Doctor:

Ask a doctor before use if you have -

a breathing problem such as emphysema or chronic bronchitis

glaucoma

trouble urinating due to an enlarged prostate gland

Active Ingredient

Diphenhydramine Hcl 25mg

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

Ask Doctor/pharmacist:

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

Questions Or Comments?

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

Principal Display Panel

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.

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.


Structured Label Content

Uses:

for relief of occasional sleeplessness

Purpose

Sleep-aid

Pregnancy (PREGNANCY)

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

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 (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

Ask Doctor:

Ask a doctor before use if you have -

a breathing problem such as emphysema or chronic bronchitis

glaucoma

trouble urinating due to an enlarged prostate gland

Active Ingredient

Diphenhydramine Hcl 25mg

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

Ask Doctor/pharmacist: (ASK DOCTOR/PHARMACIST:)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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.

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.


Advanced Ingredient Data


Raw Label Data

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