DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Microcrystalline Cellulose Polyethylene Glycol, Unspecified D&c Red No. 27 Lactose, Unspecified Form Croscarmellose Sodium Hypromellose, Unspecified Magnesium Stearate Silicon Dioxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 048;D Shape: oval Color: pink Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-01-01

Medication Information

Warnings and Precautions

Do not use – Diphen Allergy Caplet

to make a child sleepy

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

Ask a doctor before use if you have – Diphen Allergy Caplet

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

glaucoma

Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet

taking sedatives or tranquilizers

When using this product – Diphen Allergy Caplet

marked drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives and tranquilizers may increase the drowsiness effect

use caution when driving a motor vehicle or operating machinery

excitability may occur, especially in children

If pregnant or breast-feeding, – Diphen Allergy Caplet

ask a health care professional before use.

Keep out of reach of children. – Diphen Allergy Caplet

In case of overdose, contact a physician or poison control center right away (1-800-222-1222).

Indications and Usage

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

runny nose

sneezing

itching of the nose or throat

itchy, watery eyes

Temporarily relieves these symptoms due to the common cold

runny nose

sneezing

Dosage and Administration

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

runny nose

sneezing

itching of the nose or throat

itchy, watery eyes

Temporarily relieves these symptoms due to the common cold

runny nose

sneezing

Description

Diphenhydramine Hydrochloride 25 mg

Uses

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

runny nose

sneezing

itching of the nose or throat

itchy, watery eyes

Temporarily relieves these symptoms due to the common cold

runny nose

sneezing

Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN

Section 50567-7

When using this product – Diphen Allergy Caplet

marked drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives and tranquilizers may increase the drowsiness effect

use caution when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Section 50569-3

Ask a doctor before use if you have – Diphen Allergy Caplet

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

glaucoma

Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet

taking sedatives or tranquilizers

Section 50570-1

Do not use – Diphen Allergy Caplet

to make a child sleepy

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

Section 51727-6

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, – Diphen Allergy Caplet

ask a health care professional before use.

Section 55105-1

Antihistamine

Section 55106-9

Diphenhydramine Hydrochloride 25 mg

Section 60561-8

protect from light

store at room temperature 68º-77ºF (20º-25ºC)

tamper-evident sealed packets

do not use any opened or torn packets

Directions

Do not use – Diphen Allergy Caplet

to make a child sleepy

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

Ask a doctor before use if you have – Diphen Allergy Caplet

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

glaucoma

Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet

taking sedatives or tranquilizers

When using this product – Diphen Allergy Caplet

marked drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives and tranquilizers may increase the drowsiness effect

use caution when driving a motor vehicle or operating machinery

excitability may occur, especially in children

If pregnant or breast-feeding, – Diphen Allergy Caplet

ask a health care professional before use.

Keep out of reach of children. – Diphen Allergy Caplet

In case of overdose, contact a physician or poison control center right away (1-800-222-1222).

Structured Label Content

Uses (USES)

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

runny nose

sneezing

itching of the nose or throat

itchy, watery eyes

Temporarily relieves these symptoms due to the common cold

runny nose

sneezing

Indications and Usage (34067-9)

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

runny nose

sneezing

itching of the nose or throat

itchy, watery eyes

Temporarily relieves these symptoms due to the common cold

runny nose

sneezing

Dosage and Administration (34068-7)

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

runny nose

sneezing

itching of the nose or throat

itchy, watery eyes

Temporarily relieves these symptoms due to the common cold

runny nose

sneezing

Warnings and Precautions (34071-1)

Do not use – Diphen Allergy Caplet

to make a child sleepy

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

Ask a doctor before use if you have – Diphen Allergy Caplet

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

glaucoma

Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet

taking sedatives or tranquilizers

When using this product – Diphen Allergy Caplet

marked drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives and tranquilizers may increase the drowsiness effect

use caution when driving a motor vehicle or operating machinery

excitability may occur, especially in children

If pregnant or breast-feeding, – Diphen Allergy Caplet

ask a health care professional before use.

Keep out of reach of children. – Diphen Allergy Caplet

In case of overdose, contact a physician or poison control center right away (1-800-222-1222).

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN

Section 50567-7 (50567-7)

When using this product – Diphen Allergy Caplet

marked drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives and tranquilizers may increase the drowsiness effect

use caution when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Section 50569-3 (50569-3)

Ask a doctor before use if you have – Diphen Allergy Caplet

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

glaucoma

Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet

taking sedatives or tranquilizers

Section 50570-1 (50570-1)

Do not use – Diphen Allergy Caplet

to make a child sleepy

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

Section 51727-6 (51727-6)

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, – Diphen Allergy Caplet

ask a health care professional before use.

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Diphenhydramine Hydrochloride 25 mg

Section 60561-8 (60561-8)

protect from light

store at room temperature 68º-77ºF (20º-25ºC)

tamper-evident sealed packets

do not use any opened or torn packets

Directions (DIRECTIONS)

Do not use – Diphen Allergy Caplet

to make a child sleepy

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

Ask a doctor before use if you have – Diphen Allergy Caplet

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

glaucoma

Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet

taking sedatives or tranquilizers

When using this product – Diphen Allergy Caplet

marked drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives and tranquilizers may increase the drowsiness effect

use caution when driving a motor vehicle or operating machinery

excitability may occur, especially in children

If pregnant or breast-feeding, – Diphen Allergy Caplet

ask a health care professional before use.

Keep out of reach of children. – Diphen Allergy Caplet

In case of overdose, contact a physician or poison control center right away (1-800-222-1222).

Advanced Ingredient Data

[{"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27", "unii": "2LRS185U6K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE, UNSPECIFIED FORM", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"USES": "Temporarily relieves these symptoms due to hay fever or other respiratory allergies runny nose sneezing itching of the nose or throat itchy, watery eyes Temporarily relieves these symptoms due to the common cold runny nose sneezing", "34067-9": "Temporarily relieves these symptoms due to hay fever or other respiratory allergies runny nose sneezing itching of the nose or throat itchy, watery eyes Temporarily relieves these symptoms due to the common cold runny nose sneezing", "34068-7": "Temporarily relieves these symptoms due to hay fever or other respiratory allergies runny nose sneezing itching of the nose or throat itchy, watery eyes Temporarily relieves these symptoms due to the common cold runny nose sneezing", "34071-1": "Do not use – Diphen Allergy Caplet to make a child sleepy with any other product containing diphenhydramine, even one that is used on skin. Ask a doctor before use if you have – Diphen Allergy Caplet a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet taking sedatives or tranquilizers When using this product – Diphen Allergy Caplet marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast-feeding, – Diphen Allergy Caplet ask a health care professional before use. Keep out of reach of children. – Diphen Allergy Caplet In case of overdose, contact a physician or poison control center right away (1-800-222-1222).", "50565-1": "KEEP OUT OF THE REACH OF CHILDREN", "50567-7": "When using this product – Diphen Allergy Caplet marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children", "50569-3": "Ask a doctor before use if you have – Diphen Allergy Caplet a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet taking sedatives or tranquilizers", "50570-1": "Do not use – Diphen Allergy Caplet to make a child sleepy with any other product containing diphenhydramine, even one that is used on skin.", "51727-6": "croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide", "53414-9": "If pregnant or breast-feeding, – Diphen Allergy Caplet ask a health care professional before use.", "55105-1": "Antihistamine", "55106-9": "Diphenhydramine Hydrochloride 25 mg", "60561-8": "protect from light store at room temperature 68º-77ºF (20º-25ºC) tamper-evident sealed packets do not use any opened or torn packets", "DIRECTIONS": "Do not use – Diphen Allergy Caplet to make a child sleepy with any other product containing diphenhydramine, even one that is used on skin. Ask a doctor before use if you have – Diphen Allergy Caplet a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are – Diphen Allergy Caplet taking sedatives or tranquilizers When using this product – Diphen Allergy Caplet marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast-feeding, – Diphen Allergy Caplet ask a health care professional before use. Keep out of reach of children. – Diphen Allergy Caplet In case of overdose, contact a physician or poison control center right away (1-800-222-1222)."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information