Diphenhydramine Hcl Tablets, Usp 25mg

Diphenhydramine Hcl Tablets, Usp 25mg
SPL v4
SPL
SPL Set ID 872a82a1-af9a-7b0a-e053-2a91aa0ac0df
Route
ORAL
Published
Effective Date 2017-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium D&c Red No. 27 Dibasic Calcium Phosphate Dihydrate Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 400 Polyvinyl Alcohol Polysorbate 80 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: EL Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-05-12

Description

(in each tablet) Diphenhydramine HCl 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

(in each tablet) Diphenhydramine HCl 25 mg

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy nose or throat
  • temporarily relieves these symptoms of the common cold:
  • runny nose
  • sneezing
Warnings

Do not use

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

Ask a doctor before use if you have

  • trouble urinating due to an enlarged prostate gland
  • glaucoma ? a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

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

  • take every 4 to 6 hours, not more than 6 doses in 24 hours
  • Adults and children 12 years of age and older: 1 or 2 tablets
  • children 6 to under 12 years of age: 1 tablet
  • children 4 to under 6 years of age: do not use unless directed by a doctor
  • children under 4 years of age: do not use
Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

Other Information
  • each tablet contains : calcium 20 mg
  • store at controlled room temperature 20°-25°C (68°-77°F).
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Inactive Ingredients

Colloidal silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, D & C Red, Magnesium stearate, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide, Talc

Questions Or Comments

1-844-384-3723 (Mon-Fri 9AM-5PM EST) or www.safrelpharma.com

If Pregnant Or Breast Feeding;

ask a health professional before use

Keep Out of Reach of Children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

Package Label.principal Display Panel

DIPHENHYDRAMINE HYDROCHLORIDE TABLET

, USP 25 MG

ANTIHISTAMINE

* This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Benadryl� Allergy.

71309-109-10 100 Caplets

71309-109-06 600 Caplets

71309-109-01 1000 Caplets


Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy nose or throat
  • temporarily relieves these symptoms of the common cold:
  • runny nose
  • sneezing
Purpose

Antihistamine

Warnings

Do not use

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

Ask a doctor before use if you have

  • trouble urinating due to an enlarged prostate gland
  • glaucoma ? a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

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

  • take every 4 to 6 hours, not more than 6 doses in 24 hours
  • Adults and children 12 years of age and older: 1 or 2 tablets
  • children 6 to under 12 years of age: 1 tablet
  • children 4 to under 6 years of age: do not use unless directed by a doctor
  • children under 4 years of age: do not use
Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

Other Information
  • each tablet contains : calcium 20 mg
  • store at controlled room temperature 20°-25°C (68°-77°F).
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Inactive Ingredients

Colloidal silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, D & C Red, Magnesium stearate, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide, Talc

Questions Or Comments (Questions or Comments)

1-844-384-3723 (Mon-Fri 9AM-5PM EST) or www.safrelpharma.com

If Pregnant Or Breast Feeding; (If pregnant or breast-feeding;)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

DIPHENHYDRAMINE HYDROCHLORIDE TABLET

, USP 25 MG

ANTIHISTAMINE

* This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Benadryl� Allergy.

71309-109-10 100 Caplets

71309-109-06 600 Caplets

71309-109-01 1000 Caplets


Advanced Ingredient Data


Raw Label Data

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