Nighttime Sleep Aid

SPL v1

SPL

SPL Set ID 4b901ebb-ec05-4a5f-8939-071a562e780f

Route

ORAL

Published

Effective Date 2019-11-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Gelatin Glycerin Polyethylene Glycol, Unspecified Water Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2014-05-12

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:

o runny nose

o sneezing

o itchy, watery eyes

o itching of the nose or throat

• temporarily relieves these symptoms due to the common cold:

o runny nose

o sneezing

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

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 of age and over	take 1 to 2 softgels
children 6 to under 12 years of age	take 1 softgel
children under 6 years of age	do not take 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

Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information

store at room temperature 15°-30° C (59°-86° F) in a dry place
protect from heat, humidity, and light

Inactive Ingredients

gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, and white edible ink

Questions Or Comments?

Call toll free: 1-855-215-8180

When Using This Product

avoid alcoholic beverages and other drugs that cause drowsiness
drowsiness will occur
be careful when driving a motor vehicle or operating machinery

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

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

Principal Display Panel Carton Label

PuraVation Allergy Relief

Diphenhydramine HCl - 25 mg EACH

12 LIQUID-FILLED SOFTGELS

NDC 51013-108-02

Structured Label Content

Uses

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

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 of age and over	take 1 to 2 softgels
children 6 to under 12 years of age	take 1 softgel
children under 6 years of age	do not take 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

Overdose Warning (Overdose warning)

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information (Other information)

store at room temperature 15°-30° C (59°-86° F) in a dry place
protect from heat, humidity, and light

Inactive Ingredients (Inactive ingredients)

gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, and white edible ink

Questions Or Comments? (Questions or comments?)

Call toll free: 1-855-215-8180

When Using This Product (When using this product)

avoid alcoholic beverages and other drugs that cause drowsiness
drowsiness will occur
be careful when driving a motor vehicle or operating machinery

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Diphenhydramine HCl 25 mg

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

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

Principal Display Panel Carton Label (PRINCIPAL DISPLAY PANEL - Carton Label)

PuraVation Allergy Relief

Diphenhydramine HCl - 25 mg EACH

12 LIQUID-FILLED SOFTGELS

NDC 51013-108-02

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "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: o runny nose o sneezing o itchy, watery eyes o itching of the nose or throat • temporarily relieves these symptoms due to the common cold: o runny nose o sneezing", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid", "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 of age and over take 1 to 2 softgels children 6 to under 12 years of age take 1 softgel children under 6 years of age do not take 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", "Overdose warning": "Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.", "Other information": "store at room temperature 15°-30° C (59°-86° F) in a dry place protect from heat, humidity, and light", "Inactive ingredients": "gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, and white edible ink", "Questions or comments?": "Call toll free: 1-855-215-8180", "When using this product": "avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery", "Active ingredient (in each softgel)": "Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "glaucoma trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis", "PRINCIPAL DISPLAY PANEL - Carton Label": "PuraVation Allergy Relief Diphenhydramine HCl - 25 mg EACH 12 LIQUID-FILLED SOFTGELS NDC 51013-108-02"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:55.751124 · Updated: 2026-03-14T22:55:43.865902