Rite Aid 44-329

Rite Aid 44-329
SPL v3
SPL
SPL Set ID 62934d0f-b23d-4c03-9d60-a7bad41f9b42
Route
ORAL
Published
Effective Date 2023-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Microcrystalline Cellulose D&c Red No. 27 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Polyethylene Glycol, Unspecified Silicon Dioxide Stearic Acid Titanium Dioxide Starch, Corn Polyvinyl Alcohol, Unspecified Talc

Identifiers & Packaging

Pill Appearance
Imprint: 44;329 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 1990-03-02

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:

    • o
      runny nose
    • o
      itchy, watery eyes
    • o
      sneezing
    • o
      itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • o
      runny nose
    • o
      sneezing 
Directions
  • do not take more than directed

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours

adults and children 12

years and over

1 to 2 tablets

children 6 to under 12

years

1 tablet

children under 6 years

do not use

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin 

Other Information
  • each tablet contains: calcium 30 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments?

(800)-616-2471

Principal Display Panel

NDC 71205-611-20

Compare to the active ingredient in Benadryl® Allergy ULTRATAB® Tablets*

Banophen

Diphenhydramine HCl

25 mg

Antihistamine / Allergy Relief

Relieves

Sneezing,  Runny Nose,

Itchy Throat and

Itchy, Watery Eyes

Actual Size

20 Minitabs

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets.

50844    REV1220M32908

Rev. 03/21   M-17   Re-order No. 250050

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA

Repackaged by:

PROFICIENT RX LP

Thousand Oaks, CA 91320

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic beverages

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • 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.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

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

    • o
      runny nose
    • o
      itchy, watery eyes
    • o
      sneezing
    • o
      itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • o
      runny nose
    • o
      sneezing 
Purpose

Antihistamine

Directions
  • do not take more than directed

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours

adults and children 12

years and over

1 to 2 tablets

children 6 to under 12

years

1 tablet

children under 6 years

do not use

Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin 

Other Information (Other information)
  • each tablet contains: calcium 30 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

(800)-616-2471

Principal Display Panel

NDC 71205-611-20

Compare to the active ingredient in Benadryl® Allergy ULTRATAB® Tablets*

Banophen

Diphenhydramine HCl

25 mg

Antihistamine / Allergy Relief

Relieves

Sneezing,  Runny Nose,

Itchy Throat and

Itchy, Watery Eyes

Actual Size

20 Minitabs

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets.

50844    REV1220M32908

Rev. 03/21   M-17   Re-order No. 250050

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA

Repackaged by:

PROFICIENT RX LP

Thousand Oaks, CA 91320

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic beverages

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children 
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 overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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