Physicianscare Allergy

Physicianscare Allergy
SPL v2
SPL
SPL Set ID 5e31b1ff-291f-7b8c-e053-2a91aa0aedbc
Route
ORAL
Published
Effective Date 2017-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Cellulose, Microcrystalline Carnauba Wax Polyethylene Glycol 2000 Silicon Dioxide Croscarmellose Titanium Dioxide Magnesium Stearate Anhydrous Dibasic Calcium Phosphate Hypromellose 2208 (100 Mpa.s) Anhydrous Lactose Polysorbate 80 D&c Red No. 27

Identifiers & Packaging

Pill Appearance
Imprint: 048;D Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-11-01

Description

Active Ingredients (in each tablet) Diphenhydramine Hydochloride 25 mg


Medication Information

Warnings and Precautions

Warnings

Do Not Use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one that is used on the skin.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • difficuly in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers

When using this product

* marked drowsiness may occur and avoid alcoholic beverages

* 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, ask a health professional

before use

Indications and Usage

Uses



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

  • runny nose
  • sneezing
  • itching nose or throat
  • itchy-watery eyes

temporarily relieves these symptoms due to the common cold

  • runny nose
  • sneezing

Dosage and Administration

Directions

Do not use more than directed



Adults and children: (12 years and older)

Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Description

Active Ingredients (in each tablet) Diphenhydramine Hydochloride 25 mg

Section 34076-0

Other information

  • each caplet may contain: calium 25mg
  • store at room temperature 59°-86°F (15°-30°C)
  • protect from light
  • use by expiration date on packet
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Section 50565-1

Keep out of the reach of children.

In case of overdose, contact a physician or poison control center immediately.

Section 51727-6

Inactive ingredients



carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide







*may contain.

Section 51945-4

BOX16790056-revC.jpg

Section 53413-1

Questions?

1-800-835-2263

Section 55105-1

Purpose



Antihistamine



Section 55106-9

Active Ingredients (in each tablet)

Diphenhydramine Hydochloride 25 mg


Structured Label Content

Indications and Usage (34067-9)

Uses



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

  • runny nose
  • sneezing
  • itching nose or throat
  • itchy-watery eyes

temporarily relieves these symptoms due to the common cold

  • runny nose
  • sneezing

Dosage and Administration (34068-7)

Directions

Do not use more than directed



Adults and children: (12 years and older)

Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Warnings and Precautions (34071-1)

Warnings

Do Not Use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one that is used on the skin.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • difficuly in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers

When using this product

* marked drowsiness may occur and avoid alcoholic beverages

* 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, ask a health professional

before use

Section 34076-0 (34076-0)

Other information

  • each caplet may contain: calium 25mg
  • store at room temperature 59°-86°F (15°-30°C)
  • protect from light
  • use by expiration date on packet
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Section 50565-1 (50565-1)

Keep out of the reach of children.

In case of overdose, contact a physician or poison control center immediately.

Section 51727-6 (51727-6)

Inactive ingredients



carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide







*may contain.

Section 51945-4 (51945-4)

BOX16790056-revC.jpg

Section 53413-1 (53413-1)

Questions?

1-800-835-2263

Section 55105-1 (55105-1)

Purpose



Antihistamine



Section 55106-9 (55106-9)

Active Ingredients (in each tablet)

Diphenhydramine Hydochloride 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)