Allergy Relief

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Polyethylene Glycol 400 Sorbitol Propylene Glycol Glycerin Gelatin Povidone K30

Identifiers & Packaging

Pill Appearance

Imprint: 783 Shape: oval Color: white Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-08-20

Medication Information

Warnings and Precautions

Do not use

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

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

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, expecially in children

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

Indications and Usage

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

runny nose
itching of the nose or throat
itchy, watery eyes

temporarily relieves these symptoms due to the common cold:

runny nose
sneezing

Dosage and Administration

If needed, repeat dose every 4 to 6 hours donot take more than 6 doses in 24 hours

Age	Daily dosage
Adults and children 12 years of age or older	1 to 2 softgel
Children 6 to under 12 years	1 softgel
Children under 6 years of age	do not use this product

Description

Diphenhydramine HCl 25mg

Section 34088-5

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Section 50565-1

Keep out of reach of children.

Section 51727-6

polyethylene glycol 400, propylene glycol, gelatin, glycerin, sorbitol 70%, povidone k-30

Section 51945-4

Section 55105-1

Antihistamine

Section 55106-9

Diphenhydramine HCl 25mg

Section 60561-8

store between 20-25°C (68-77ºF), Excursions permitted between 15°C-30°C (59-86ºF).
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Structured Label Content

Indications and Usage (34067-9)

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

runny nose
itching of the nose or throat
itchy, watery eyes

temporarily relieves these symptoms due to the common cold:

runny nose
sneezing

Dosage and Administration (34068-7)

If needed, repeat dose every 4 to 6 hours donot take more than 6 doses in 24 hours

Age	Daily dosage
Adults and children 12 years of age or older	1 to 2 softgel
Children 6 to under 12 years	1 softgel
Children under 6 years of age	do not use this product

Warnings and Precautions (34071-1)

Do not use

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

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

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, expecially in children

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

Section 34088-5 (34088-5)

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

polyethylene glycol 400, propylene glycol, gelatin, glycerin, sorbitol 70%, povidone k-30

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Diphenhydramine HCl 25mg

Section 60561-8 (60561-8)

store between 20-25°C (68-77ºF), Excursions permitted between 15°C-30°C (59-86ºF).
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose itching of the nose or throat itchy, watery eyes temporarily relieves these symptoms due to the common cold: runny nose sneezing", "34068-7": "If needed, repeat dose every 4 to 6 hours donot take more than 6 doses in 24 hours Age Daily dosage Adults and children 12 years of age or older 1 to 2 softgel Children 6 to under 12 years 1 softgel Children under 6 years of age do not use this product", "34071-1": "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin 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 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, expecially in children If pregnant or breast-feeding, ask a health professional before use.", "34088-5": "Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.", "50565-1": "Keep out of reach of children.", "51727-6": "polyethylene glycol 400, propylene glycol, gelatin, glycerin, sorbitol 70%, povidone k-30", "55105-1": "Antihistamine", "55106-9": "Diphenhydramine HCl 25mg", "60561-8": "store between 20-25°C (68-77ºF), Excursions permitted between 15°C-30°C (59-86ºF). TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information