DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Benzyl Alcohol Butylparaben D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Lactose, Unspecified Form Magnesium Stearate Methylparaben Polysorbate 80 Propylparaben Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance

Imprint: AP;20 Shape: oval Color: pink Color: white Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2019-12-30

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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 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. (1-800-222-1222)

Directions

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times 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

each capsule contains: calcium 20 mg
store at room temperature 20°-25°C (68°-77°F). Avoid high humidity. Protect from light

Inactive Ingredients

benzyl alcohol, butyl paraben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methyl paraben, polysorbate 80, propyl paraben, sodium lauryl sulfate

Questions Or Comments?

Call toll free: 1-800-456-7077

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.

Active Ingredient (in Each Capsule)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Principal Display Panel 25 Mg Pouch Label

Safetec

of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.

Buffalo NY 14215

Allergy Relief

Diphenhydramine HCl

antihistamine 2 Capsules

Principal Display Panel – 50 Pouches Carton Label

Safetec^®

of America, Inc.

*Compare to the active ingredient in Benadryl^®

NDC 61010-4409-1

Allergy Relief

Diphenhydramine HCl 25 mg

PUSH TO OPEN

Dispense through opening

Antihistamine

Itchy Watery Eyes
Sneezing
Runny Nose

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches 2 Capsules per pouch

Graphic-Untitled

Principal Display Panel – 100 Pouches Carton Label

Safetec^®

of America, Inc.

*Compare to the active ingredient in Benadryl^®

NDC 61010-4409-2

Allergy Relief

Diphenhydramine HCl 25 mg – Antihistamine

Itchy Watery Eyes
Sneezing
Runny Nose

PUSH TO OPEN

Dispense through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches 2 Capsules per pouch

Structured Label Content

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 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. (1-800-222-1222)

Purpose

Antihistamine

Directions

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times 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)

each capsule contains: calcium 20 mg
store at room temperature 20°-25°C (68°-77°F). Avoid high humidity. Protect from light

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, butyl paraben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methyl paraben, polysorbate 80, propyl paraben, sodium lauryl sulfate

Questions Or Comments? (Questions or comments?)

Call toll free: 1-800-456-7077

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, ask a health professional before use.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCl 25 mg

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
trouble urinating due to an enlarged prostate gland

Principal Display Panel 25 Mg Pouch Label (Principal Display Panel - 25 mg Pouch Label)

Safetec

of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.

Buffalo NY 14215

Allergy Relief

Diphenhydramine HCl

antihistamine 2 Capsules

Principal Display Panel – 50 Pouches Carton Label

Safetec^®

of America, Inc.

*Compare to the active ingredient in Benadryl^®

NDC 61010-4409-1

Allergy Relief

Diphenhydramine HCl 25 mg

PUSH TO OPEN

Dispense through opening

Antihistamine

Itchy Watery Eyes
Sneezing
Runny Nose

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches 2 Capsules per pouch

Graphic-Untitled

Principal Display Panel – 100 Pouches Carton Label

Safetec^®

of America, Inc.

*Compare to the active ingredient in Benadryl^®

NDC 61010-4409-2

Allergy Relief

Diphenhydramine HCl 25 mg – Antihistamine

Itchy Watery Eyes
Sneezing
Runny Nose

PUSH TO OPEN

Dispense through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches 2 Capsules per pouch

Advanced Ingredient Data

[{"name": "Diphenhydramine", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "benzyl alcohol", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "butylparaben", "unii": "3QPI1U3FV8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C red NO. 28", "unii": "767IP0Y5NH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE, UNSPECIFIED FORM", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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 due to the common cold: runny nose sneezing", "42229-5": "Drug Facts", "50565-1": "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)", "Purpose": "Antihistamine", "Directions": "take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times 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": "each capsule contains: calcium 20 mg store at room temperature 20°-25°C (68°-77°F). Avoid high humidity. Protect from light", "Inactive ingredients": "benzyl alcohol, butyl paraben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methyl paraben, polysorbate 80, propyl paraben, sodium lauryl sulfate", "Questions or comments?": "Call toll free: 1-800-456-7077", "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.", "Active ingredient (in each capsule)": "Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "Principal Display Panel - 25 mg Pouch Label": "Safetec of America, Inc. DO NOT USE IF POUCH IS TORN OR DAMAGED Manufactured for Safetec of America, Inc. Buffalo NY 14215 Allergy Relief Diphenhydramine HCl antihistamine 2 Capsules", "Principal Display Panel – 50 Pouches Carton Label": "Safetec ® of America, Inc. *Compare to the active ingredient in Benadryl ® NDC 61010-4409-1 Allergy Relief Diphenhydramine HCl 25 mg PUSH TO OPEN Dispense through opening Antihistamine Itchy Watery Eyes Sneezing Runny Nose TAMPER EVIDENT UNIT DOSE POUCHES DO NOT USE IF POUCH IS TORN OR DAMAGED 50 Pouches 2 Capsules per pouch Graphic-Untitled", "Principal Display Panel – 100 Pouches Carton Label": "Safetec ® of America, Inc. *Compare to the active ingredient in Benadryl ® NDC 61010-4409-2 Allergy Relief Diphenhydramine HCl 25 mg – Antihistamine Itchy Watery Eyes Sneezing Runny Nose PUSH TO OPEN Dispense through opening TAMPER EVIDENT UNIT DOSE POUCHES DO NOT USE IF POUCH IS TORN OR DAMAGED 100 Pouches 2 Capsules per pouch"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information