160r Winco Foods 67091 381 Diphenhydramine Hcl 25 Mg 24ct And 100ct

160r Winco Foods 67091 381 Diphenhydramine Hcl 25 Mg 24ct And 100ct
SPL v2
SPL
SPL Set ID c34e71c2-e974-a4b3-e053-2a95a90af89a
Route
ORAL
Published
Effective Date 2022-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Cellulose, Microcrystalline Polyethylene Glycol 400 Carnauba Wax Silicon Dioxide Croscarmellose Sodium D&c Red No. 27 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Polysorbate 80 Titanium Dioxide Magnesium Stearate Hypromelloses

Identifiers & Packaging

Pill Appearance
Imprint: T;061 Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-01-15

Description

Active ingredients (in each caplet) Diphenhydramine HCl 25 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

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

• runny nose

• itchy, watery eyes

• sneezing

• itchy nose or throat

temporarily relieves these symptoms due to the common cold:

• runny nose

• sneezing

Dosage and Administration

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 caplets

children 6 to under 12 years of age: 1 caplet

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

Description

Active ingredients (in each caplet) Diphenhydramine HCl 25 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product

• marked drowsiness may occur

• avoid alcoholic drinks

• alcohol, sedatives, and tranquilizers may increase drowsiness

• excitability may occur, especially in children

• be careful when driving a motor vehicle or operating machinery

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

• glaucoma

• trouble urinating due to enlarged prostate gland

• a breathing problem such as emphysema or chronic bronchitis

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

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

Section 51945-4

Section 53413-1

Questions? Call 1-800-824-1706

Monday - Friday 9 am-4pm MST

Section 53414-9

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

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredients (in each caplet)

Diphenhydramine HCl 25 mg

Section 60561-8

Other information

each caplet contains: calcium 25 mg

• protect from light

• store at 25°C (77° F) excursions permitted between 15°-30°C (59°-86°F)

• use by expiration date on package


Structured Label Content

Indications and Usage (34067-9)

Uses

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

• runny nose

• itchy, watery eyes

• sneezing

• itchy nose or throat

temporarily relieves these symptoms due to the common cold:

• runny nose

• sneezing

Dosage and Administration (34068-7)

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 caplets

children 6 to under 12 years of age: 1 caplet

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

Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product

• marked drowsiness may occur

• avoid alcoholic drinks

• alcohol, sedatives, and tranquilizers may increase drowsiness

• excitability may occur, especially in children

• be careful when driving a motor vehicle or operating machinery

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

• glaucoma

• trouble urinating due to enlarged prostate gland

• a breathing problem such as emphysema or chronic bronchitis

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)

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 1-800-824-1706

Monday - Friday 9 am-4pm MST

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Diphenhydramine HCl 25 mg

Section 60561-8 (60561-8)

Other information

each caplet contains: calcium 25 mg

• protect from light

• store at 25°C (77° F) excursions permitted between 15°-30°C (59°-86°F)

• use by expiration date on package


Advanced Ingredient Data


Raw Label Data

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