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

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg


Medication Information

Active Ingredient

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 
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

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

Description

Diphenhydramine HCl 25 mg

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

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

Questions Or Comments?

(800)-616-2471

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.

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

Active Ingredient (Active ingredient (in each tablet))

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 
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

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

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

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

Questions Or Comments? (Questions or comments?)

(800)-616-2471

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.

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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