Akron Pharma, Inc.

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Gelatin Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Propylparaben Sodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2021-01-15

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine Hydrochloride 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

Section 51945-4

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

Age	Dose
adults and children 12 years and over	1 to 2 capsules
children 6 to under 12 years of age	1 capsule
children under 6 years of age	do not use this product in children under 6 years of age

Do Not Use

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

Other Information

store at temperature 15° to 30° C (59° to 86°F)
do not use if either capsule band or imprinted safety seal under cap is broken or missing
protect from moisture

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline

cellulose, propyl paraben sodium.

Questions Or Comments?

Call toll-free 1-877-225-6999

Mfg Lic .No: TN/DRUGS/558/1997

Manufactured for:

Akron Pharma, Inc,

373 RT US 46 W, Building E,

Suite 117, Fairfield, NJ 07004

When Using This Product

marked drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
excitability may occur, especially in children
be careful when driving a motor vehicle or operating machinery

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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have

glaucoma
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis

Active Ingredient (in Each Banded Capsule)

Diphenhydramine Hydrochloride 50 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

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

Section 51945-4 (51945-4)

Purpose

Antihistamine

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

Age	Dose
adults and children 12 years and over	1 to 2 capsules
children 6 to under 12 years of age	1 capsule
children under 6 years of age	do not use this product in children under 6 years of age

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 temperature 15° to 30° C (59° to 86°F)
do not use if either capsule band or imprinted safety seal under cap is broken or missing
protect from moisture

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline

cellulose, propyl paraben sodium.

Questions Or Comments? (Questions or comments?)

Call toll-free 1-877-225-6999

Mfg Lic .No: TN/DRUGS/558/1997

Manufactured for:

Akron Pharma, Inc,

373 RT US 46 W, Building E,

Suite 117, Fairfield, NJ 07004

When Using This Product (When using this product)

marked drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
excitability may occur, especially in children
be careful when driving a motor vehicle or operating machinery

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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

glaucoma
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis

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

Diphenhydramine Hydrochloride 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

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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", "Purpose": "Antihistamine", "Directions": "take every 4 to 6 hours do not take more than 6 doses in 24 hours Age Dose adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age", "Do not use": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Other information": "store at temperature 15° to 30° C (59° to 86°F) do not use if either capsule band or imprinted safety seal under cap is broken or missing protect from moisture", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, propyl paraben sodium.", "Questions or comments?": "Call toll-free 1-877-225-6999 Mfg Lic .No: TN/DRUGS/558/1997 Manufactured for: Akron Pharma, Inc, 373 RT US 46 W, Building E, Suite 117, Fairfield, NJ 07004", "When using this product": "marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children be careful when driving a motor vehicle or operating machinery", "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 (1-800-222-1222) right away.", "Ask a doctor before use if you have": "glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis", "Active ingredient (in each banded capsule)": "Diphenhydramine Hydrochloride 50 mg", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information