Premier Value Sleep-aid Softgels

Premier Value Sleep-aid Softgels
SPL v2
SPL
SPL Set ID a6e94bea-7348-4b09-9244-9ef7b31a16b4
Route
ORAL
Published
Effective Date 2015-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Glycerin Methylparaben Polyethylene Glycols Propylparaben Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: R060 Shape: capsule Color: purple Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-11-14

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. 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.

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 50567-7

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
Section 50568-5

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

Section 50569-3

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
Section 50570-1

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
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

adults & children

12 yrs & over

One dose = TWO 25 mg Softgels (50 mg)

at bed time if needed or as directed by a doctor

Other Information
  • store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F) and high humidity
  • protect from light
Inactive Ingredients

FD&C blue 1, FD&C red 40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

Principal Display Panel

Premier Value

Nighttime

Sleep-Aid Softgels

Diphenhydramine HCl

Non Habit Forming

Not for treating Cold or Flu

See Warnings

Compare to ZzzQuil® Liquicaps® active ingredient*

24 SOFTGELS

Active Ingredients (in Each Softgel)

Diphenhydramine HCl 25 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. 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.

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 50567-7 (50567-7)

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
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 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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
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

adults & children

12 yrs & over

One dose = TWO 25 mg Softgels (50 mg)

at bed time if needed or as directed by a doctor

Other Information (Other information)
  • store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F) and high humidity
  • protect from light
Inactive Ingredients (Inactive ingredients)

FD&C blue 1, FD&C red 40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Premier Value

Nighttime

Sleep-Aid Softgels

Diphenhydramine HCl

Non Habit Forming

Not for treating Cold or Flu

See Warnings

Compare to ZzzQuil® Liquicaps® active ingredient*

24 SOFTGELS

Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

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