0835 - Cvs

0835 - Cvs
SPL v4
SPL
SPL Set ID 6dfbb8ba-0cdb-57a2-e053-2991aa0a54e0
Route
ORAL
Published
Effective Date 2020-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
D&c Red No. 28 Gelatin Anhydrous Lactose Fd&c Blue No. 1 Fd&c Red No. 40 Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: CPC;835 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-20

Description

Active ingredient (in each banded capsule) Diphenhydramine HCI 25 mg.

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Active ingredient (in each banded capsule) Diphenhydramine HCI 25 mg.

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 
  • runny nose 
  • sneezing 
  • itchy, watery eyes 
  • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold: 
  • runny nose 
  • sneezing
Section 34088-5

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

Section 42229-5

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Benadryl®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-34601

Section 51945-4

CVSHealth

Compare to the active ingredient in Benadryl®*

Allergy Relief

DIPHENHYDRAMINE HYDROCHLORIDE,

25 mg - Antihistamine

Relief of:

Sneezing, Runny nose,

Itchy, watery eyes, Itchy throat

365 CAPSULES

Directions
  • take every 4 to 6 hours 
  • do not take more than 6 doses in 24 hours

adults and children 12 years of age and over

1 to 2 capsules

children 6 to under 12 years of age

1 capsule

children under 6 years of age

do not use this product in children under 6 years of age

Do Not Use
  • to make a child sleepy 
  • with any other product containing diphenhydramine, even one used on skin
Drug Facts

Active ingredient (in each banded capsule)

Diphenhydramine HCI 25 mg.

Other Information
  • 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

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch

Questions Or Comments?

1-800-231-4670

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
If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis 
  • glaucoma 
  • trouble urinating due to an enlarged 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: 
  • runny nose 
  • sneezing 
  • itchy, watery eyes 
  • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold: 
  • runny nose 
  • sneezing
Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Benadryl®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-34601

Section 51945-4 (51945-4)

CVSHealth

Compare to the active ingredient in Benadryl®*

Allergy Relief

DIPHENHYDRAMINE HYDROCHLORIDE,

25 mg - Antihistamine

Relief of:

Sneezing, Runny nose,

Itchy, watery eyes, Itchy throat

365 CAPSULES

Purpose

Antihistamine

Directions
  • take every 4 to 6 hours 
  • do not take more than 6 doses in 24 hours

adults and children 12 years of age and over

1 to 2 capsules

children 6 to under 12 years of age

1 capsule

children under 6 years of age

do not use this product in children under 6 years of age

Do Not Use (Do not use)
  • to make a child sleepy 
  • with any other product containing diphenhydramine, even one used on skin
Drug Facts

Active ingredient (in each banded capsule)

Diphenhydramine HCI 25 mg.

Other Information (Other information)
  • 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)

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch

Questions Or Comments? (Questions or comments?)

1-800-231-4670

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

ask a health professional before use.

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 
  • trouble urinating due to an enlarged 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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