drug facts

drug facts
SPL v2
SPL
SPL Set ID af2f8389-d696-4060-8abd-6eda04e73009
Route
oral
Published
Effective Date 2023-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
croscarmellose sodium d&c red no. 27 aluminum lake hypromellose, unspecified lactose, unspecified form magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified silicon dioxide titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 048 Shape: oval Color: pink Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-12-06

Purpose

Antihistamine

Description

 Diphenhydramine HCl 25mg


Medication Information

Warnings

Do not use

with any other products containing diphenhydramine, including ones used on skin

to make children sleepy

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

Ask a doctor or pharmacist before use if youare taking sedatives or tranquilizers

When using this product:

Marked drowsiness may occur

Avoid alcoholic beverages

Alcohol, sedatives, and tranquilizers may increase drowsiness

Be careful when driving a motor vehicle or operating machinery

Excitability may occur, especially in children

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

Uses

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

Sneezing, runny nose, itchy / watery eyes, and itching of the nose or throat

Purpose

Antihistamine

Directions

Take every 4 to 6 hours, or as directed by a doctor.  Do not take more than 6 times in 24 hours

Adults and children 12 years of age and older: 1 to 2 caplets

Children 6 to 12 years:1 caplet

Children under 6:do not use

Inactive Ingredients

croscarmellose sodium, D C Red 27 aluminum lake, hypromellose, lactose, magnesium stearate, microcystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Description

 Diphenhydramine HCl 25mg

Section 51945-4
Active Ingredient

 Diphenhydramine HCl 25mg

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.


Structured Label Content

Warnings

Do not use

with any other products containing diphenhydramine, including ones used on skin

to make children sleepy

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

Ask a doctor or pharmacist before use if youare taking sedatives or tranquilizers

When using this product:

Marked drowsiness may occur

Avoid alcoholic beverages

Alcohol, sedatives, and tranquilizers may increase drowsiness

Be careful when driving a motor vehicle or operating machinery

Excitability may occur, especially in children

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

Uses

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

Sneezing, runny nose, itchy / watery eyes, and itching of the nose or throat

Purpose

Antihistamine

Directions

Take every 4 to 6 hours, or as directed by a doctor.  Do not take more than 6 times in 24 hours

Adults and children 12 years of age and older: 1 to 2 caplets

Children 6 to 12 years:1 caplet

Children under 6:do not use

Inactive Ingredients

croscarmellose sodium, D C Red 27 aluminum lake, hypromellose, lactose, magnesium stearate, microcystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Section 51945-4 (51945-4)
Active Ingredient

 Diphenhydramine HCl 25mg

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

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.


Advanced Ingredient Data


Raw Label Data

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