160r 55910 959 dollar general diphenhydramine hydrochloride 24ct

160r 55910 959 dollar general diphenhydramine hydrochloride 24ct
SPL v3
SPL
SPL Set ID be2207b7-b8f8-7fba-e053-2a95a90abd16
Route
oral
Published
Effective Date 2021-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
carnauba wax silicon dioxide dibasic calcium phosphate dihydrate hypromelloses titanium dioxide microcrystalline cellulose magnesium stearate polyethylene glycol 400 croscarmellose sodium d&c red no. 27 aluminum lake polysorbate 80

Identifiers & Packaging

Pill Appearance
Imprint: T061 Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-07-24

Description

Active Ingredient (in each tablet) Diphenhydramine Hydrochloride 25mg


Medication Information

Warnings and Precautions

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Active Ingredient

Active Ingredient (in each tablet)

Diphenhydramine Hydrochloride 25mg

Indications and Usage

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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 tablets

children 6 to under 12 years of age: 1 tablet

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

Other Information

Other information

  • each tablet 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
Description

Active Ingredient (in each tablet) Diphenhydramine Hydrochloride 25mg

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 an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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 or Comments? call 1-888-309-9030

Section 53414-9

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

Section 55105-1

Purpose

Antihistamine


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Active Ingredient (55106-9)

Active Ingredient (in each tablet)

Diphenhydramine Hydrochloride 25mg

Indications and Usage (34067-9)

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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 tablets

children 6 to under 12 years of age: 1 tablet

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

Other Information (OTHER INFORMATION)

Other information

  • each tablet 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
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 an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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 or Comments? call 1-888-309-9030

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antihistamine


Advanced Ingredient Data


Raw Label Data

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