welmate diphenhydramine 50 mg 73581-020

welmate diphenhydramine 50 mg 73581-020
SPL v3
SPL
SPL Set ID 4b012549-3958-43c1-9de7-897c5d8b20d3
Route
oral
Published
Effective Date 2023-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (50 mg)
Inactive Ingredients
ferrosoferric oxide d&c red no. 28 fd&c blue no. 1 fd&c red no. 40 gelatin lactose monohydrate magnesium stearate silicon dioxide sodium lauryl sulfate

Identifiers & Packaging

Pill Appearance
Imprint: PH013 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-08-01

Purpose

Antihistamine

Description

Diphenhydramine HCL 50 mg


Medication Information

Purpose

Antihistamine

Other Information
  • Store at 20-25 °C (68-77 °F)
Inactive Ingredients

black iron oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate

Description

Diphenhydramine HCL 50 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 symptons due to common cold: 
  • runny nose
  • sneezing
Section 51945-4

welmate

Compare to active ingredient in BENADRYL® Allergy Extra Strength*

ANTIHISTAMINE

Allergy Relief

Diphenhydramine

HCl Capsules, USP  50 mg

For temporary relief of:

Sneezing

Runny nose

Itchy watery eyes

Itchy nose or throat

1000 CAPSULES

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Warnings:

Do Not Use
  • to make a child sleepy
  • With any other product containing Diphenhydramine HCL, even one used on skin
Directions:
  • take every 4 to 6 hours, or as directed by a doctor
  • do not exceed 6 doses in 24 hours
adults and children 12 years and over 1 capsule                                     
children under 12 years ask a doctor

Questions Or Comments?

(866) 933-6337 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in 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)

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
Active Ingredient (in Each Banded Capsule)

Diphenhydramine HCL 50 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

Purpose

Antihistamine

Other Information (Other information)
  • Store at 20-25 °C (68-77 °F)
Inactive Ingredients (Inactive ingredients)

black iron oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate

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 symptons due to common cold: 
  • runny nose
  • sneezing
Section 51945-4 (51945-4)

welmate

Compare to active ingredient in BENADRYL® Allergy Extra Strength*

ANTIHISTAMINE

Allergy Relief

Diphenhydramine

HCl Capsules, USP  50 mg

For temporary relief of:

Sneezing

Runny nose

Itchy watery eyes

Itchy nose or throat

1000 CAPSULES

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Warnings:

Do Not Use (Do not use)
  • to make a child sleepy
  • With any other product containing Diphenhydramine HCL, even one used on skin
Directions:
  • take every 4 to 6 hours, or as directed by a doctor
  • do not exceed 6 doses in 24 hours
adults and children 12 years and over 1 capsule                                     
children under 12 years ask a doctor

Questions Or Comments? (Questions or comments?)

(866) 933-6337 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
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)

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

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
Active Ingredient (in Each Banded Capsule) (Active ingredient (in each banded capsule))

Diphenhydramine HCL 50 mg

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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