Allergy Antihistamine Capsules

Allergy Antihistamine Capsules
SPL v3
SPL
SPL Set ID af5053d8-ba02-4cdf-877f-8c1e368dafe0
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
Butylparaben D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Lactose Monohydrate Magnesium Stearate Methylparaben Polysorbate 80 Propylparaben Water Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: S832 Shape: capsule Color: pink Color: white Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-01

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Section 42229-5

Drug Facts

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 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9

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

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over 1 to 2 capsules
children 6 to under 12 years 1 capsule
children under 6 years do not use
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • store at room temperature between 20-25 °C (68-77 °F)
Inactive Ingredients

butylparaben, D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose monohydrate, magnesium stearate, methylparaben, polysorbate 80, propylparaben, purified water, sodium lauryl sulphate, starch

Questions Or Comments

1-800-632-6900

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
Active Ingredient (in Each Banded Capsule)

Diphenhydramine HCl 25 mg

Principal Display Panel 25 Mg Capsule Bottle Carton

COMPARE TO the active ingredient of BENADRYL® *See bottom panel

NDC 30142-832-84

Kroger®

Allergy

Capsules

Diphenhydramine HCl

25 mg

ANTIHISTAMINE

OUR PHARMACIST RECOMMENDED

actual

size

TEMPORARILY

RELIEVES:

Sneezing Runny Nose

Itchy, Watery Eyes

Itchy Throat

100 CAPSULES


Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Section 42229-5 (42229-5)

Drug Facts

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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over 1 to 2 capsules
children 6 to under 12 years 1 capsule
children under 6 years do not use
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • store at room temperature between 20-25 °C (68-77 °F)
Inactive Ingredients (Inactive ingredients)

butylparaben, D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose monohydrate, magnesium stearate, methylparaben, polysorbate 80, propylparaben, purified water, sodium lauryl sulphate, starch

Questions Or Comments (Questions or comments)

1-800-632-6900

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
Active Ingredient (in Each Banded Capsule) (Active ingredient (in each banded capsule))

Diphenhydramine HCl 25 mg

Principal Display Panel 25 Mg Capsule Bottle Carton (PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Carton)

COMPARE TO the active ingredient of BENADRYL® *See bottom panel

NDC 30142-832-84

Kroger®

Allergy

Capsules

Diphenhydramine HCl

25 mg

ANTIHISTAMINE

OUR PHARMACIST RECOMMENDED

actual

size

TEMPORARILY

RELIEVES:

Sneezing Runny Nose

Itchy, Watery Eyes

Itchy Throat

100 CAPSULES


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)