SPL v2
SPL
SPL Set ID e4e4004f-77e3-569d-e053-2a95a90a73fe
Route
ORAL
Published
Effective Date 2022-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Croscarmellose Sodium Fd&c Red No. 3 Talc Polyvinyl Alcohol, Unspecified Silicon Dioxide Anhydrous Dibasic Calcium Phosphate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: I3 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-28

Description

Diphenhydramine HCl 25 mg


Medication Information

Warnings and Precautions

Do not use

to make a child sleepy

with any other product containing diphenhydramine, even one used on skin

Indications and Usage

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

runny nose

sneezing

itchy, watery eyes

itching of the nose or throat

temporarily relieves these symptoms due to the common cold:

runny nose

sneezing

Dosage and Administration

take every 4 to 6 hours do not take more than 6 doses in 24 hours

adults & children 12 years & over 1 to 2 tablets

children 6 to under 12 years 1 tablet

children under 6 years do not use this product in children under 6 years of age

Description

Diphenhydramine HCl 25 mg

Section 50565-1

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

Section 50567-7

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

Section 50568-5

taking sedatives or tranquilizers

Section 50569-3

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

Section 51727-6

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 3, magnesium stearate, microcrystalline cellulose, polyethylene glycol, hydroxy propyl methyl cellulose talc, titanium dioxide

Section 51945-4

Section 53413-1

609-642-6380

Section 53414-9

ask a health professional before use.

Section 55105-1

Antihistamine

Section 55106-9

Diphenhydramine HCl 25 mg


Structured Label Content

Indications and Usage (34067-9)

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

runny nose

sneezing

itchy, watery eyes

itching of the nose or throat

temporarily relieves these symptoms due to the common cold:

runny nose

sneezing

Dosage and Administration (34068-7)

take every 4 to 6 hours do not take more than 6 doses in 24 hours

adults & children 12 years & over 1 to 2 tablets

children 6 to under 12 years 1 tablet

children under 6 years do not use this product in children under 6 years of age

Warnings and Precautions (34071-1)

Do not use

to make a child sleepy

with any other product containing diphenhydramine, even one used on skin

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

taking sedatives or tranquilizers

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 3, magnesium stearate, microcrystalline cellulose, polyethylene glycol, hydroxy propyl methyl cellulose talc, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

609-642-6380

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

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