Cvs 44-685-allergy Delisted

Cvs 44-685-allergy Delisted
SPL v10
SPL
SPL Set ID 4e388604-a4cb-4f34-bfdf-4bbc09739b34
Route
ORAL
Published
Effective Date 2025-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
D&c Red No. 27 Aluminum Lake D&c Red No. 30 Aluminum Lake Dextrose Monohydrate Ethylcellulose, Unspecified Fd&c Blue No. 1 Aluminum Lake Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Mannitol Stearic Acid Sucralose Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: 44;685 Shape: round Color: purple Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-05-31 Until 2026-08-31

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

Directions
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over 1 to 2 chewable tablets
children 6 to under 12 years 1 chewable tablet
children under 6 years do not use
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • 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)
  • avoid high humidity

  • see end flap for expiration date and lot number
Inactive Ingredients

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions Or Comments?

1-800-426-9391

Principal Display Panel

♥CVS Health® 

Chewable Tablets

NDC 69842-685-44

Allergy  Relief

DIPHENHYDRAMINE

HYDROCHLORIDE, 25 mg

CHEWABLE TABLETS

Antihistamine

Relief of:

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy throat

For Ages 6 Years & Over

18 CHEWABLE TABLETS

Actual Size

Grape Flavored

Chew or crush

tablets completely

before swallowing.

TAMPER EVIDENT: DO NOT

USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-18615

50844     REV0119B68544

100% money back

guaranteed.


CVS.com/returnpolicy

CVS 44-685
When Using This Product
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages

  • 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

Active Ingredient (in Each Chewable Tablet)

Diphenhydramine HCl 25 mg

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

Purpose

Antihistamine

Directions
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over 1 to 2 chewable tablets
children 6 to under 12 years 1 chewable tablet
children under 6 years do not use
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • 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)
  • avoid high humidity

  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

♥CVS Health® 

Chewable Tablets

NDC 69842-685-44

Allergy  Relief

DIPHENHYDRAMINE

HYDROCHLORIDE, 25 mg

CHEWABLE TABLETS

Antihistamine

Relief of:

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy throat

For Ages 6 Years & Over

18 CHEWABLE TABLETS

Actual Size

Grape Flavored

Chew or crush

tablets completely

before swallowing.

TAMPER EVIDENT: DO NOT

USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-18615

50844     REV0119B68544

100% money back

guaranteed.


CVS.com/returnpolicy

CVS 44-685
When Using This Product (When using this product)
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages

  • 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

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

Diphenhydramine HCl 25 mg

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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