329r Dip Hcl

329r Dip Hcl
SPL v2
SPL
SPL Set ID ed899055-0cbb-45bd-92c8-cbef2fc7c361
Route
ORAL
Published
Effective Date 2010-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol Polysorbate 80 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: help Shape: capsule Color: white Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-03-01

Description

Active Ingredient (in each caplet) Diphenhydramine Hcl 25 mg


Medication Information

Warnings and Precautions

Warnings

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

Indications and Usage

Uses: Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies; runny nose, itchy watery eyes; sneezing; itchy nose or throat

Temporarily relieves these symptoms due to the common cold: runny nose; sneezing

Dosage and Administration

Directions:

Take every 4 to 6 hours

Do not take more than 6 doses in 24 hours

Adults and children 12 years of age and over - 1 to 2 caplets

Children 6 to under 12 years of age - 1 caplet

Children under 6 years of age - Do not use this product in children under 6 years of age

Description

Active Ingredient (in each caplet) Diphenhydramine Hcl 25 mg

Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50567-7

When using this product

Avoid alcoholic drinks

marked drowsiness may occur

Alcohol, sedatives, and tranquilizers may increase drowsiness

Excitability may occur, especially in children

Be careful when driving a motor vehicle or operating machinery

Section 50568-5
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Section 50569-3

Ask a doctor before use if you have

glaucoma;

trouble urinating due to an enlarged prostate gland;

a breathing problem such as emphysema or chronic bronchitis

Section 50570-1

Do not use

to make a child sleepy; with any other product containing diphenhydramine, even one used on skin.

Section 51727-6

Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide
Section 51945-4

Enter section text here

Section 53414-9
If pregnant or breast-feeding ask a health professional before use.
Section 55105-1

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

runny nose; itchy water eyes sneezing;itchy nose or throat

Temporarily relieves these symptoms due to the common cold: runny nose; sneezing

Section 55106-9

Active Ingredient

(in each caplet)

Diphenhydramine Hcl 25 mg


Structured Label Content

Indications and Usage (34067-9)

Uses: Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies; runny nose, itchy watery eyes; sneezing; itchy nose or throat

Temporarily relieves these symptoms due to the common cold: runny nose; sneezing

Dosage and Administration (34068-7)

Directions:

Take every 4 to 6 hours

Do not take more than 6 doses in 24 hours

Adults and children 12 years of age and over - 1 to 2 caplets

Children 6 to under 12 years of age - 1 caplet

Children under 6 years of age - Do not use this product in children under 6 years of age

Warnings and Precautions (34071-1)

Warnings

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

Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50567-7 (50567-7)

When using this product

Avoid alcoholic drinks

marked drowsiness may occur

Alcohol, sedatives, and tranquilizers may increase drowsiness

Excitability may occur, especially in children

Be careful when driving a motor vehicle or operating machinery

Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Section 50569-3 (50569-3)

Ask a doctor before use if you have

glaucoma;

trouble urinating due to an enlarged prostate gland;

a breathing problem such as emphysema or chronic bronchitis

Section 50570-1 (50570-1)

Do not use

to make a child sleepy; with any other product containing diphenhydramine, even one used on skin.

Section 51727-6 (51727-6)

Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide
Section 51945-4 (51945-4)

Enter section text here

Section 53414-9 (53414-9)
If pregnant or breast-feeding ask a health professional before use.
Section 55105-1 (55105-1)

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

runny nose; itchy water eyes sneezing;itchy nose or throat

Temporarily relieves these symptoms due to the common cold: runny nose; sneezing

Section 55106-9 (55106-9)

Active Ingredient

(in each caplet)

Diphenhydramine Hcl 25 mg


Advanced Ingredient Data


Raw Label Data

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