family dollar services, inc. allergy drug facts

family dollar services, inc. allergy drug facts
SPL v2
SPL
SPL Set ID 4ac36cef-845b-4c3c-9788-72191737a918
Route
oral
Published
Effective Date 2020-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
carnauba wax crospovidone (120 .mu.m) d&c red no. 27 hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 stearic acid titanium dioxide dibasic calcium phosphate dihydrate

Identifiers & Packaging

Pill Appearance
Imprint: L479;25 Shape: oval Color: pink Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-07-22

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg


Medication Information

Active Ingredient

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 of the common cold:
  • runny nose
  • sneezing
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 and over

1 to 2 tablets

children 6 to under 12 years

1 tablet

children under 6 years

do not use

Other Information
  • each tablet contains: calcium 20 mg
  • store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
Inactive Ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Description

Diphenhydramine HCl 25 mg

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ULTRATABS®

ALLERGY

Diphenhydramine HCl 25 mg / antihistamine

Relieves:

sneezing

itchy throat

runny nose

itchy, watery eyes

Actual Size

100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

100 Tablets

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Questions Or Comments?

1-800-719-9260

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
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

Active Ingredient (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 of the common cold:
  • runny nose
  • sneezing
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 and over

1 to 2 tablets

children 6 to under 12 years

1 tablet

children under 6 years

do not use

Other Information (Other information)
  • each tablet contains: calcium 20 mg
  • store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
Inactive Ingredients (Inactive ingredients)

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ULTRATABS®

ALLERGY

Diphenhydramine HCl 25 mg / antihistamine

Relieves:

sneezing

itchy throat

runny nose

itchy, watery eyes

Actual Size

100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

100 Tablets

Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Questions Or Comments? (Questions or comments?)

1-800-719-9260

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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Before Use If You Have (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
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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