SPL v1
SPL
SPL Set ID a96484ba-c618-ee52-e053-2a95a90a3344
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: S4 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-06-29

Description

Diphenhydramine Hcl 25mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine Hcl 25mg

Uses:

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

sneezing

itchy, watery eyes

temporarily relieves these symptoms due to the common cold:

runny nose

sneezing

Pregnancy

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

Warnings:

Do not use - to make a child sleepy - with any other product containing diphenhydramine, even one used on skin

Directions

if needed, repeat dose every 4 to 6 hours

do not take more than 6 times in 24 hours

adults and children 12 years of age or older - 1 to 2 caplets

children 6 to under 12 years - 1 caplet

children under 6 years of age - do not use.

Ask Doctor:

Ask a doctor before use if you have - glaucoma - troble urinating due to an enlarged prostate gland - a breathing problem such as emphysema or chronic bronchitis

Active Ingredient

Diphenhydramine Hcl 25mg

Other Information

each tablets contains: calcium 24 mg - store between 20-25°C (68-77°F). Avoid high humidity. Protect from moisture and light

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

Label

When Using This Product

marked drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

excitability may occur, especially in children

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.


Structured Label Content

Uses:

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

sneezing

itchy, watery eyes

temporarily relieves these symptoms due to the common cold:

runny nose

sneezing

Purpose

Antihistamine

Pregnancy (PREGNANCY)

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

Warnings:

Do not use - to make a child sleepy - with any other product containing diphenhydramine, even one used on skin

Directions (DIRECTIONS)

if needed, repeat dose every 4 to 6 hours

do not take more than 6 times in 24 hours

adults and children 12 years of age or older - 1 to 2 caplets

children 6 to under 12 years - 1 caplet

children under 6 years of age - do not use.

Ask Doctor:

Ask a doctor before use if you have - glaucoma - troble urinating due to an enlarged prostate gland - a breathing problem such as emphysema or chronic bronchitis

Active Ingredient

Diphenhydramine Hcl 25mg

Other Information (OTHER INFORMATION)

each tablets contains: calcium 24 mg - store between 20-25°C (68-77°F). Avoid high humidity. Protect from moisture and light

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)

Label

When Using This Product (WHEN USING THIS PRODUCT)

marked drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Keep Out of Reach of Children (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.


Advanced Ingredient Data


Raw Label Data

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