160r Timely 49483-061 Diphenhydramine Hcl 25mg

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Carnauba Wax Silicon Dioxide Croscarmellose Sodium D&c Red No. 27 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Hypromellose, Unspecified Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 400 Polysorbate 80 Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: T061 Shape: capsule Color: pink Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-05-01

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 ingredient (in each caplet) Diphenhydramine HCI 25 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Centre (1-800-222-1222) 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 an 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 no 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 or comments? call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each caplet)

Diphenhydramine HCI 25 mg

Other Information

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 Centre (1-800-222-1222) 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 an 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 no 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 or comments? call 1-877-290-4008

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 ingredient (in each caplet)

Diphenhydramine HCI 25 mg

Other Information (OTHER INFORMATION)

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

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Raw Label Data

All Sections (JSON)

{"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", "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", "34071-1": "Warnings", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Centre (1-800-222-1222) right away.", "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", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "50569-3": "Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis", "50570-1": "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "51727-6": "Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red no 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol(PEG) 400, polysorbate 80, titanium dioxide", "53413-1": "Questions or comments? call 1-877-290-4008", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Antihistamine", "55106-9": "Active ingredient (in each caplet) Diphenhydramine HCI 25 mg", "OTHER INFORMATION": "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"}