Diphenhydramine Hcl 25 Mg

Diphenhydramine Hcl 25 Mg
SPL v1
SPL
SPL Set ID 7c1a38de-555f-46e6-91c5-2d14aa9ab5d1
Route
ORAL
Published
Effective Date 2018-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Anhydrous Dibasic Calcium Phosphate Microcrystalline Cellulose Croscarmellose Sodium Silicon Dioxide Magnesium Stearate Polyvinyl Alcohol Talc Titanium Dioxide Polyethylene Glycol D&c Red No. 27 Aluminum Lake Lecithin, Soybean

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-07-31

Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

Uses

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

runny nose

sneezing

itchy, watery eyes

temporarily relieves these symptoms due to the common cold:

runny nose

sneezing

Section 42228-7

If pregnant or breast-feeding, ask a health professional before use. 

Section 50565-1

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

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

Section 50569-3

Ask a doctor before use if you have

  • glaucoma
  • troble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Section 51945-4

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Directions
  • if needed, repeat dose every 4 to 6 hours
  • do not take more than 6 times in 24 hours
  • adults and children 12 years of age or older - 1 to 2 caplets
  • children 6 to under 12 years - 1 caplet
  • children under 6 years of age - do not use.
Drug Facts

Diphenhydramine HCl 25 mg

Other Information

each tablets contains:

calcium 15 mg

store between 20-25°C (68-77°F). Avoid high humidity

Inactive Ingredients

dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, OPADRY II

Questions Or Comments?

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Distributed by:

Pioneer Life Sciences

40E Cotters Lane, Suite A

East Brunswick, NJ 08816

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Structured Label Content

Uses

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

runny nose

sneezing

itchy, watery eyes

temporarily relieves these symptoms due to the common cold:

runny nose

sneezing

Section 42228-7 (42228-7)

If pregnant or breast-feeding, ask a health professional before use. 

Section 50565-1 (50565-1)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • glaucoma
  • troble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Section 51945-4 (51945-4)

Purpose

Antihistamine

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Directions
  • if needed, repeat dose every 4 to 6 hours
  • do not take more than 6 times in 24 hours
  • adults and children 12 years of age or older - 1 to 2 caplets
  • children 6 to under 12 years - 1 caplet
  • children under 6 years of age - do not use.
Drug Facts

Diphenhydramine HCl 25 mg

Other Information (Other information)

each tablets contains:

calcium 15 mg

store between 20-25°C (68-77°F). Avoid high humidity

Inactive Ingredients (Inactive ingredients)

dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, OPADRY II

Questions Or Comments? (Questions or comments?)

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Distributed by:

Pioneer Life Sciences

40E Cotters Lane, Suite A

East Brunswick, NJ 08816

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Advanced Ingredient Data


Raw Label Data

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