SPL v6
SPL
SPL Set ID ac1860cb-da95-45bf-9261-19f39c56ddfe
Route
ORAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 High Fructose Corn Syrup Poloxamer 407 Propylene Glycol Water Sodium Benzoate Sodium Citrate Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-12-10

Description

Diphenhydramine HCL 50 mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCL 50 mg

Uses
  • reduces time to  fall asleep if you have difficulty falling asleep
  • for relief of occassional sleeplessness
Warnings

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences.

Directions
  • take only as recommended
  • use dosage cup or tablespoon
 Age  Dose
 Adults and children 12 years and over  One dose = 2 tablespoons (30 mL) at bedtime if needed or as directed by a doctor
 Children under 12 years  Do not use

Do Not Use
  • for children under 12 years of age.
  • with any other product containing diphenhydramine, even one used on skin
  • with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products
Drug Facts

Diphenhydramine HCL 50 mg

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Other Information
  • each 30 mL dose (2 tablespoons) contains: sodium 23 mg
  • dosage cup provided
  • store at room temperature
Inactive Ingredients

citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, high fructose corn syrup, poloxamer 407, propllene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin

When Using This Product
  • do not use more than directed
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Kep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If

sleeplessness persists continously 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.

Ask A Doctor Before Use If You Have
  • heart disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as asthma, emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers or any other sleep aid

Discount Drug Mart Food Fair Night Time Sleep Aid Product Label

* COMPARE TO THE ACTIVE INGREDIENT IN ZzzQuil™NIGHTTIME SLEEP-AID

DISCOUNT

drug mart

FOOD FAIR

NIGHT TIME SLEEP-AID

Diphenhydramine HCL

Non-Habit Forming

Warming Berry Flavored Liquid

Not for treating Cold or Flu

12 FL OZ (354 mL)

* This product is not manufactured or distributed by Proctor and Gamble owner of the registered trademark ZzzQuil™

LR-055

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

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Structured Label Content

Uses
  • reduces time to  fall asleep if you have difficulty falling asleep
  • for relief of occassional sleeplessness
Purpose

Nighttime sleep-aid

Warnings

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences.

Directions
  • take only as recommended
  • use dosage cup or tablespoon
 Age  Dose
 Adults and children 12 years and over  One dose = 2 tablespoons (30 mL) at bedtime if needed or as directed by a doctor
 Children under 12 years  Do not use

Do Not Use (Do not use)
  • for children under 12 years of age.
  • with any other product containing diphenhydramine, even one used on skin
  • with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products
Drug Facts

Diphenhydramine HCL 50 mg

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Other Information (Other information)
  • each 30 mL dose (2 tablespoons) contains: sodium 23 mg
  • dosage cup provided
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, high fructose corn syrup, poloxamer 407, propllene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin

When Using This Product (When using this product)
  • do not use more than directed
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Kep Out of Reach of Children (Kep out of reach of children)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continously 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as asthma, emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers or any other sleep aid

Discount Drug Mart Food Fair Night Time Sleep Aid Product Label (DISCOUNT drug mart FOOD FAIR NIGHT TIME SLEEP-AID product label)

* COMPARE TO THE ACTIVE INGREDIENT IN ZzzQuil™NIGHTTIME SLEEP-AID

DISCOUNT

drug mart

FOOD FAIR

NIGHT TIME SLEEP-AID

Diphenhydramine HCL

Non-Habit Forming

Warming Berry Flavored Liquid

Not for treating Cold or Flu

12 FL OZ (354 mL)

* This product is not manufactured or distributed by Proctor and Gamble owner of the registered trademark ZzzQuil™

LR-055

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

res


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