0110-cvs

0110-cvs
SPL v1
SPL
SPL Set ID 1059b55b-c218-843f-e063-6294a90af2fe
Route
ORAL
Published
Effective Date 2024-02-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Silicon Dioxide Titanium Dioxide Triacetin Light Mineral Oil Talc Hypromelloses Lactose Monohydrate Microcrystalline Cellulose Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: C110 Shape: oval Color: white Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-31

Description

Active ingredient (in each caplet) Diphenhydramine HCl 50 mg


Medication Information

Description

Active ingredient (in each caplet) Diphenhydramine HCl 50 mg

Uses

temporarily relives symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

temporarily relives 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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/pharmacy CVS.com® 1-800-SHOP CVS

Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.

V-34601

TAMPER EVIDENT: DO NOT USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN.

RETAIN OUTER CARTON FOR COMPLETE PRODUCT INFORMATION.

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

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product

  • marked drowsiness mau 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
Section 50568-5

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

Section 50569-3

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
Section 50570-1

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Section 51727-6

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silicon dioxide, stearic acid, talc, titanium dioxide, triacetin.

Section 51945-4

Compare to the active ingredient in Benadryl® Allergy Extra Strength*

Extra Strength

Allergy Relief

Diphenhydramine HCl, 50mg

Antihistamine

Temporatry relief of

Sneezing

Itchy throat

Runny nose

Itchy, watery eyes

24 Caplets

Section 53413-1

1-800-231-4670

Section 53414-9

If pregnant or brest-feeding, ask a health professional before use.

Section 55105-1

Purpose

Antihistamine

Directions

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 of age and over 1 caplet
children under 12 years of age do not use

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

Other Information
  • store in a dry place at 15º - 30º C (59º - 86º F).
  • ptotect from moisture


Structured Label Content

Uses

temporarily relives symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

temporarily relives 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)

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/pharmacy CVS.com® 1-800-SHOP CVS

Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.

V-34601

TAMPER EVIDENT: DO NOT USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN.

RETAIN OUTER CARTON FOR COMPLETE PRODUCT INFORMATION.

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product

  • marked drowsiness mau 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
Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Section 51727-6 (51727-6)

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silicon dioxide, stearic acid, talc, titanium dioxide, triacetin.

Section 51945-4 (51945-4)

Compare to the active ingredient in Benadryl® Allergy Extra Strength*

Extra Strength

Allergy Relief

Diphenhydramine HCl, 50mg

Antihistamine

Temporatry relief of

Sneezing

Itchy throat

Runny nose

Itchy, watery eyes

24 Caplets

Section 53413-1 (53413-1)

1-800-231-4670

Section 53414-9 (53414-9)

If pregnant or brest-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antihistamine

Directions

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 of age and over 1 caplet
children under 12 years of age do not use

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

Other Information (Other information)
  • store in a dry place at 15º - 30º C (59º - 86º F).
  • ptotect from moisture


Advanced Ingredient Data


Raw Label Data

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