e4e4004f-77e3-569d-e053-2a95a90a73fe

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

Active Ingredient

Diphenhydramine HCl 25 mg

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


Structured Label Content

Warnings and Precautions (34071-1)

Do not use

to make a child sleepy

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

Active Ingredient (55106-9)

Diphenhydramine HCl 25 mg

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

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


Advanced Ingredient Data


Raw Label Data

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