Premier Value Nighttime Sleep-aid

Premier Value Nighttime Sleep-aid
SPL v7
SPL
SPL Set ID 6d24b6e1-7959-47c6-a09b-c7e00a437495
Route
ORAL
Published
Effective Date 2024-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Potassium Citrate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-12-10
Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Uses
  • •
    for the relief of occasional sleeplessness
  • •
    reduces time to fall asleep if you have difficulty falling asleep
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 only one dose per day (24 hours) - see Overdose warning
  • •
    use dose cup or tablespoon

adults & children 12 yrs & over

One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor
Do Not Use
  • •
    for children under 12 years of age
  • •
    with any other product containing diphenhydramine, even one used on skin
  • •
    with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
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
  • •
    each 30 mL dose (2 tablespoons) contains: sodium 23 mg
  • •
    store at room temperature
  • •
    protect from light. Does not meet USP <671>.
Inactive Ingredients

anhydrous citric acid, carboxymethylcelluose sodium, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

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
Ask A Doctor Before Use If You Have
  • •
    a breathing problem such as asthma, emphysema, or chronic bronchitis
  • •
    glaucoma
  • •
    difficulty in urination due to enlargement of the prostate gland
  • •
    heart disease
Principal Display Panel 354 Ml Bottle Label

Premier Value

Nighttime

Sleep-Aid

Diphenhydramine HCl /

  • •
    Non-Habit Forming

Berry Flavor

Not for treating Cold or Flu

See Warnings

12 FL OZ (354 ml)

Active Ingredients (in Each 30 Ml Dose Cup Or 2 Tablespoons)

Diphenhydramine HCl 50 mg

Structured Label Content

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

Nighttime sleep-aid

Directions
  • •
    take only one dose per day (24 hours) - see Overdose warning
  • •
    use dose cup or tablespoon

adults & children 12 yrs & over

One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor
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 other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
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)
  • •
    each 30 mL dose (2 tablespoons) contains: sodium 23 mg
  • •
    store at room temperature
  • •
    protect from light. Does not meet USP <671>.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcelluose sodium, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

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
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • •
    a breathing problem such as asthma, emphysema, or chronic bronchitis
  • •
    glaucoma
  • •
    difficulty in urination due to enlargement of the prostate gland
  • •
    heart disease
Principal Display Panel 354 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label)

Premier Value

Nighttime

Sleep-Aid

Diphenhydramine HCl /

  • •
    Non-Habit Forming

Berry Flavor

Not for treating Cold or Flu

See Warnings

12 FL OZ (354 ml)

Active Ingredients (in Each 30 Ml Dose Cup Or 2 Tablespoons) (Active ingredients (in each 30 mL dose cup or 2 tablespoons))

Diphenhydramine HCl 50 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:05.742023 · Updated: 2026-03-14T23:04:35.063520