Publix Super Markets, Inc. Sleep Aid Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Carnauba Wax Crospovidone (120 .mu.m) Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Fd&c Blue No. 2 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: L431 Shape: oval Color: blue Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2001-07-24

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Use

for relief of occasional sleeplessness

Directions

adults and children 12

years and over

take 2 caplets at bedtime if needed, or as directed by a doctor

children under 12 years

do not use

Do Not Use

•
in children under 12 years of age
•
with any other product containing diphenhydramine, even one used on skin

Other Information

•
each caplet contains: calcium 15 mg
•
store at 68-77°F (20-25°C). Avoid high humidity. Protect from light.
•
do not use if blister unit is broken or torn

Inactive Ingredients

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Principal Display Panel

P

sleep aid

DIPHENHYDRAMINE HCl 25 mg

ACTUAL SIZE

Nighttime Sleep Aid

• Does not Contain Pain Reliever

• For a restful night’s sleep

• Safe, Non-Habit Forming

24 CAPLETS

Compare to Simply Sleep^® Nighttime Sleep Aid active ingredient

When Using This Product

•
avoid alcoholic drinks
•
drowsiness may occur
•
do not drive a motor vehicle or operate machinery

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Caplet)

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Keep Out of Reach of Children. Overdose Warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Structured Label Content

Use

for relief of occasional sleeplessness

Purpose

Nighttime sleep-aid

Directions

adults and children 12

years and over

take 2 caplets at bedtime if needed, or as directed by a doctor

children under 12 years

do not use

Do Not Use (Do not use)

•
in children under 12 years of age
•
with any other product containing diphenhydramine, even one used on skin

Other Information (Other information)

•
each caplet contains: calcium 15 mg
•
store at 68-77°F (20-25°C). Avoid high humidity. Protect from light.
•
do not use if blister unit is broken or torn

Inactive Ingredients (Inactive ingredients)

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Principal Display Panel

P

sleep aid

DIPHENHYDRAMINE HCl 25 mg

ACTUAL SIZE

Nighttime Sleep Aid

• Does not Contain Pain Reliever

• For a restful night’s sleep

• Safe, Non-Habit Forming

24 CAPLETS

Compare to Simply Sleep^® Nighttime Sleep Aid active ingredient

When Using This Product (When using this product)

•
avoid alcoholic drinks
•
drowsiness may occur
•
do not drive a motor vehicle or operate machinery

Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Keep Out of Reach of Children. Overdose Warning: (Keep out of reach of children. Overdose warning:)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE (120 .MU.M)", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "for relief of occasional sleeplessness", "Purpose": "Nighttime sleep-aid", "Directions": "adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years do not use", "Do not use": "• in children under 12 years of age • with any other product containing diphenhydramine, even one used on skin", "Other information": "• each caplet contains: calcium 15 mg • store at 68-77°F (20-25°C). Avoid high humidity. Protect from light. • do not use if blister unit is broken or torn", "Inactive ingredients": "carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide", "Principal Display Panel": "P sleep aid DIPHENHYDRAMINE HCl 25 mg ACTUAL SIZE Nighttime Sleep Aid • Does not Contain Pain Reliever • For a restful night’s sleep • Safe, Non-Habit Forming 24 CAPLETS Compare to Simply Sleep ® Nighttime Sleep Aid active ingredient", "When using this product": "• avoid alcoholic drinks • drowsiness may occur • do not drive a motor vehicle or operate machinery", "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.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Active ingredient (in each caplet)": "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", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers", "Keep out of reach of children. Overdose warning:": "In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."}

Publix Super Markets, Inc. Sleep Aid Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information