2834a-cvs

2834a-cvs
SPL v3
SPL
SPL Set ID b45296a9-e3f0-a4cb-e053-2995a90a1686
Route
ORAL
Published
Effective Date 2021-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Magnesium Stearate Dibasic Calcium Phosphate Dihydrate Microcrystalline Cellulose Silicon Dioxide Triacetin Stearic Acid Talc Titanium Dioxide Hypromelloses Croscarmellose Sodium Light Mineral Oil

Identifiers & Packaging

Pill Appearance
Imprint: CPC;2824 Shape: oval Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-23

Description

Active ingredient (in each tablet) Diphenhydramine HCl 25 mg


Medication Information

Description

Active ingredient (in each tablet) Diphenhydramine HCl 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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy LIQUIGELS®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2020 CVS/pharmacy CVS.com®

1-800-SHOP CVS

Product of China

V-34601

Section 50565-1

Keep out of reach of children.

Section 51727-6

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Silica, Stearic Acid, Talc, Titanium Dioxide and Triacetin

Section 51945-4

CVS Health

Compare to the active ingredient in Benadryl® Allergy LIQUIGELS®*

Allergy Relief

Diphehydramine HCl, 25 mg

Antihistamine

Relief of: Sneezing; Runny nose; Itchy,watery eyes; Itchy throat

200 Tablets

Section 53414-9

If pregnant or breast-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 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

■ To make a child sleepy

■ With any other product containing diphenhydramine, even one used on skin

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Other Information

■ Each tablet contains: calcium 37 mg

■ Store between 20-25° C (68-77° F). Protect from light.

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

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)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy LIQUIGELS®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2020 CVS/pharmacy CVS.com®

1-800-SHOP CVS

Product of China

V-34601

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Silica, Stearic Acid, Talc, Titanium Dioxide and Triacetin

Section 51945-4 (51945-4)

CVS Health

Compare to the active ingredient in Benadryl® Allergy LIQUIGELS®*

Allergy Relief

Diphehydramine HCl, 25 mg

Antihistamine

Relief of: Sneezing; Runny nose; Itchy,watery eyes; Itchy throat

200 Tablets

Section 53414-9 (53414-9)

If pregnant or breast-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 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)

■ To make a child sleepy

■ With any other product containing diphenhydramine, even one used on skin

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Other Information (Other information)

■ Each tablet contains: calcium 37 mg

■ Store between 20-25° C (68-77° F). Protect from light.

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

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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